In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution

• Sponsor: Terumo BCT (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02298842
• Collaborator: (none)
• Enrollment: 87
• Locations: 2
• Arms: 2
• Duration (Months): 6.2
• Patients Per Site: 43.5
• Patients Per Site Per Month: 7

Study Details

Study Description

Brief Summary

This study sought to verify that the in vitro quality (functional assays) of platelets collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored for 1, 5, and 7 days meet FDA requirements.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Device: Platelets stored in InterSol; Device: Platelets stored in Plasma	N/A

Detailed Description

Platelets suspended in platelet additive solutions (PAS) have been collected and transfused in Europe for over 20 years. These PAS solutions outside of the United States (US) are not tied to an apheresis device; however in the US, PAS solutions have traditionally been linked to a corresponding apheresis device.

Currently in the US, there are two solutions approved by the Food and Drug Administration (FDA) as a PAS for the replacement of 65% plasma in platelet components. Isoplate Solution is approved for use with the Trima Accel® Automated Blood Collection System (Trima Accel System) and InterSol Solution is approved for use with the Amicus Separator System.

This study is designed to provide blood centers with the option to use either Isoplate or InterSol when collecting platelets for use with PAS. Terumo BCT is pursuing approval for InterSol Solution in combination with the Trima Accel System.

This is a randomized, paired, prospective, open-label, multi-center study. Up to 120 healthy adult subjects will be enrolled in this study to ensure 60 paired evaluable data points across two Investigational Sites. Evaluable is defined as two completed platelet products with 100mL plasma that do not meet any of the protocol analysis exclusion criteria.

The additional platelet donors account for screen failures, incomplete procedures, and protocol exclusions.

Two units of platelets will be collected from each subject: one Test unit collected as a hyperconcentrated platelet product with 100 mL of concurrent plasma and one Control unit of platelets in plasma collected according to standard procedure. The Test unit will be suspended in 65% Intersol/35% plasma immediately after collection; the Control unit will be maintained in 100% plasma.

Eligible donors who have signed an informed consent will be enrolled. Randomization will occur in a ratio of 1:1 to one of the following Treatment Arms:

Arm A: Collection of one Test unit followed by collection of one Control unit Arm B:

Collection of one Control unit followed by collection of one Test unit

The standard apheresis platelet units collected in the Control arm will mirror the hyperconcentrated platelet units in the Test arm in terms of yield and final concentration.

SUBJECT PROCEDURES

Screening can be performed within 30 days of the apheresis procedure or combined with the first Apheresis Visit.

The following evaluations will be performed:

1. Informed consent will be obtained prior to initiating any study specific procedures

2. Eligibility will be confirmed

3. Demographics (age, gender, ethnic origin), height, and weight

4. Complete blood count (CBC) for hemoglobin and platelet count on subjects new to the Investigative Site that do not have historical hemoglobin and/or platelet count measurements

Apheresis Visit

The following procedures will be performed at both the first and second Apheresis Visits:

1. Eligibility will be confirmed

2. Finger stick hemoglobin

3. First apheresis procedure will be performed

Subject will return to the Site in 6 to 8 days following the first apheresis collection for the second apheresis collection. This will conclude the subject's participation.

Apheresis procedures will be run according to the instructions and precautions described in the commercially available Trima Accel Operator's Manual for use with Version 6.4.

The Investigator or designee will perform the venipuncture, monitor the subject during the collection, assess and provide any interventions for adverse effects, remove the needle, dress the puncture site and monitor subject through recovery.

The following will be documented:

1. Trima Procedure details

2. Adverse events

3. Medications to treat AEs

4. Device deficiencies

Study Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: In Vitro Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution
• Study Start Date: Nov 5, 2015
• Actual Primary Completion Date: May 12, 2016
• Actual Study Completion Date: May 12, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Platelets Stored in Plasma Platelets stored in Plasma	Device: Platelets stored in Plasma; A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Experimental: Test Platelets Stored in InterSol Platelets stored in InterSol	Device: Platelets stored in InterSol; A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.

Outcome Measures

Primary Outcome Measures

1. pH of Platelets at Day 5 [Day 5]

   The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.

2. pH of Platelets at Day 7 [Day 7]

   The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.

Secondary Outcome Measures

1. Percent of Platelets Activated as Measured by P-selectin [Day 5]

   Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.

2. Percent of Extent of Shape Change [Day 5]

   Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality.

3. Percent of Platelets Exhibiting Hypotonic Shock Response [Day 5]

   Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.

4. Platelet Morphology [Day 5]

   Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.

5. Percent of Platelets Activated as Measured by P-selectin [Day 7]

   Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.

6. Percent of Extent of Shape Change [Day 7]

   Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. Higher value is considered to indicate better platelet quality.

7. Percent of Platelets Exhibiting Hypotonic Shock Response [Day 7]

   Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.

8. Platelet Morphology [Day 7]

   Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age 18 years of age or older

• Meet the inclusion criteria defined by the Investigational Site for an apheresis double platelet with plasma collection on the Trima Accel System. These criteria are based on American Association of Blood Banks (AABB) standards. Note: Subjects who are deferred from volunteer community donations because of travel restrictions, piercings or tattoos may participate in the study.

Exclusion Criteria:

• None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hoxworth Blood Center	Cincinnati	Ohio	United States	45267
2	Blood Center of Wisconsin	Milwaukee	Wisconsin	United States	53233

Sponsors and Collaborators

• Terumo BCT

Investigators

• Principal Investigator: Jose Cancelas-Perez, MD, PhD, Hoxworth Blood Center
• Principal Investigator: Mehraboon S Irani, MD, Clood Center of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cohn CS, Stubbs J, Schwartz J, Francis R, Goss C, Cushing M, Shaz B, Mair D, Brantigan B, Heaton WA. A comparison of adverse reaction rates for PAS C versus plasma platelet units. Transfusion. 2014 Aug;54(8):1927-34. doi: 10.1111/trf.12597. Epub 2014 Apr 16.
• Diedrich B, Sandgren P, Jansson B, Gulliksson H, Svensson L, Shanwell A. In vitro and in vivo effects of potassium and magnesium on storage up to 7 days of apheresis platelet concentrates in platelet additive solution. Vox Sang. 2008 Feb;94(2):96-102. Epub 2007 Nov 22.
• Dumont LJ, Cancelas JA, Graminske S, Friedman KD, Vassallo RR, Whitley PH, Rugg N, Dumont DF, Herschel L, Siegal AH, Szczepiorkowski ZM, Fender L, Razatos A. In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution. Transfusion. 2013 May;53(5):972-80. doi: 10.1111/j.1537-2995.2012.03841.x. Epub 2012 Aug 6.
• Dumont LJ, VandenBroeke T, Ault KA. Platelet surface P-selectin measurements in platelet preparations: an international collaborative study. Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT). Transfus Med Rev. 1999 Jan;13(1):31-42.
• Gulliksson H, AuBuchon JP, Vesterinen M, Sandgren P, Larsson S, Pickard CA, Herschel I, Roger J, Tracy JE, Langweiler M; Biomedical Excellence for Safer Transfusion Working Party of the International Society of Blood Transfusion. Storage of platelets in additive solutions: a pilot in vitro study of the effects of potassium and magnesium. Vox Sang. 2002 Apr;82(3):131-6.
• Ringwald J, Walz S, Zimmermann R, Zingsem J, Strasser E, Weisbach V, Eckstein R. Hyperconcentrated platelets stored in additive solution: aspects on productivity and in vitro quality. Vox Sang. 2005 Jul;89(1):11-8.

• Responsible Party: Terumo BCT
• ClinicalTrials.gov Identifier: NCT02298842
• Other Study ID Numbers: CTS-5051
• First Posted: Nov 24, 2014
• Last Update Posted: Jul 21, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Terumo BCT: Healthy Adults

Study Results

Participant Flow

Pre-assignment Detail	87 volunteers signed consent and were enrolled in the study, but 2 were screen fails and therefore did not participate in the study

Arm/Group Title	InterSol First, Then Plasma	Plasma First, Then InterSol
Arm/Group Description	Platelets collected in InterSol, then platelets collected in plasma	Platelets collected in plasma, then platelets collected in InterSol
Period Title: First Platelet Donation (Day 0)
STARTED	44	41
COMPLETED	38	36
NOT COMPLETED	6	5
Period Title: First Platelet Donation (Day 0)
STARTED	38	36
COMPLETED	30	30
NOT COMPLETED	8	6

Baseline Characteristics

Arm/Group Title	InterSol First, Then Plasma	Plasma First, Then InterSol	Total
Arm/Group Description	Platelets collected in InterSol, then platelets collected in plasma	Platelets collected in plasma, then platelets collected in InterSol	Total of all reporting groups
Overall Participants	44	41	85
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	41 93.2%	37 90.2%	78 91.8%
>=65 years	3 6.8%	4 9.8%	7 8.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.9 (14.10)	43.3 (14.98)	42.1 (14.49)
Sex: Female, Male (Count of Participants)
Female	15 34.1%	13 31.7%	28 32.9%
Male	29 65.9%	28 68.3%	57 67.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.3%	1 2.4%	2 2.4%
Not Hispanic or Latino	43 97.7%	40 97.6%	83 97.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	44 100%	41 100%	85 100%
Height (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	69.5 (3.12)	68.5 (3.43)	69.0 (3.30)
Weight (lbs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [lbs]	197.9 (34.38)	188.7 (30.87)	193.4 (32.87)
Total Blood Volume (TBV) (mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL]	5380.1 (770.93)	5172.5 (757.45)	5280.0 (767.04)

Outcome Measures

1. Primary Outcome

Title	pH of Platelets at Day 5
Description	The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.

Arm/Group Title	Test Platelets Collected and Stored in InterSol	Control Platelets Collected and Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.	Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Measure Participants	60	60
Mean (Standard Deviation) [pH]	7.184 (0.0718)	7.414 (0.0975)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Platelets Collected and Stored in InterSol, Control Platelets Collected and Stored in Plasma
	Comments	A "success" is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria.
	Type of Statistical Test	Non-Inferiority
	Comments	The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH> 6.2 will be at least 95%. This will be achieved if zero failures (pH<=6.2) is seen.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Simple sample proportion
	Estimated Value	100
	Confidence Interval	(1-Sided) 95%; 95.1 to
	Parameter Dispersion	Type: Standard Deviation; Value: 0
	Estimation Comments	Estimated proportion is 100%. Hence standard deviation is estimated as 0.

2. Primary Outcome

Title	pH of Platelets at Day 7
Description	The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.

Arm/Group Title	Test Platelets Collected and Stored in InterSol	Control Platelets Collected and Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.	Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Measure Participants	60	60
Mean (Standard Deviation) [pH]	7.152 (0.0855)	7.335 (0.1313)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Platelets Collected and Stored in InterSol, Control Platelets Collected and Stored in Plasma
	Comments	A "success" is defined as pH22°C at Day 5 and Day 7 being at least 6.2. A one-sided 95% lower confidence limit will be used to assess the proportion of successes at Day 5 and Day 7. If the lower limit of the one-sided 95% confidence interval exceeds 0.95, the Test product will meet the FDA acceptance criteria.
	Type of Statistical Test	Non-Inferiority
	Comments	The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH> 6.2 will be at least 95%. This will be achieved if zero failures (pH<=6.2) is seen.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Simple sample proportion
	Estimated Value	100
	Confidence Interval	(1-Sided) 95%; 95.1 to
	Parameter Dispersion	Type: Standard Deviation; Value: 0
	Estimation Comments	Estimated proportion is 100%. Hence standard deviation is estimated as 0.

3. Secondary Outcome

Title	Percent of Platelets Activated as Measured by P-selectin
Description	Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.

Arm/Group Title	Test Platelets Collected and Stored in InterSol	Control Platelets Collected and Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.	Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Measure Participants	60	60
Mean (Standard Deviation) [Percent of Platelets Activated]	26.324 (7.6052)	9.354 (4.4110)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Platelets Collected and Stored in InterSol, Control Platelets Collected and Stored in Plasma
	Comments	The null hypothesis is that P-selectin's mean difference, Test - 1.25 * Control, is greater than or equal to 0, and the alternative is that the mean difference is less than 0.
	Type of Statistical Test	Non-Inferiority
	Comments	If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	15.099
	Confidence Interval	(1-Sided) 97.5%; to 16.738
	Parameter Dispersion	Type: Standard Deviation; Value: 5.6367
	Estimation Comments	Estimated from an ANCOVA with effects of treatment and subject nested within sequence.

4. Secondary Outcome

Title	Percent of Extent of Shape Change
Description	Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.

Arm/Group Title	Arm A - Test Platelets Stored in InterSol	Arm B - Platelets Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.	Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Measure Participants	60	60
Mean (Standard Deviation) [% extent of shape change]	24.109 (5.9968)	30.658 (5.1498)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Platelets Collected and Stored in InterSol, Control Platelets Collected and Stored in Plasma
	Comments	The null hypothesis is that ESC's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.
	Type of Statistical Test	Non-Inferiority
	Comments	Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-0.418
	Confidence Interval	(1-Sided) 97.5%; -1.544 to
	Parameter Dispersion	Type: Standard Deviation; Value: 4.5531
	Estimation Comments	Estimated from an ANCOVA with effects of treatment and subject nested within sequence.

5. Secondary Outcome

Title	Percent of Platelets Exhibiting Hypotonic Shock Response
Description	Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.

Arm/Group Title	Test Platelets Collected and Stored in InterSol	Control Platelets Collected and Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.	Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Measure Participants	60	60
Mean (Standard Deviation) [% of hypotonic shock response]	44.507 (8.4013)	56.467 (9.6924)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Platelets Collected and Stored in InterSol, Control Platelets Collected and Stored in Plasma
	Comments	The null hypothesis is that HSR's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.
	Type of Statistical Test	Non-Inferiority
	Comments	Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.667
	Confidence Interval	(1-Sided) 97.5%; -2.499 to
	Parameter Dispersion	Type: Standard Deviation; Value: 6.7882
	Estimation Comments	Estimated from an ANCOVA with effects of treatment and subject nested within sequence.

6. Secondary Outcome

Title	Platelet Morphology
Description	Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.
Time Frame	Day 5

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.

Arm/Group Title	Test Platelets Collected and Stored in InterSol	Control Platelets Collected and Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.	Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Measure Participants	60	60
Mean (Standard Deviation) [scores on a scale]	293.1 (31.76)	308.7 (33.30)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Platelets Collected and Stored in InterSol, Control Platelets Collected and Stored in Plasma
	Comments	The null hypothesis is that Morphology's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.
	Type of Statistical Test	Non-Inferiority
	Comments	Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	46.1
	Confidence Interval	(1-Sided) 97.5%; 40.020 to
	Parameter Dispersion	Type: Standard Deviation; Value: 23.056
	Estimation Comments	Estimated from an ANCOVA with effects of treatment and subject nested within sequence.

7. Secondary Outcome

Title	Percent of Platelets Activated as Measured by P-selectin
Description	Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.

Arm/Group Title	Test Platelets Collected and Stored in InterSol	Control Platelets Collected and Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.	Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Measure Participants	60	60
Mean (Standard Deviation) [Percent of Platelets Activated]	29.392 (8.0418)	14.232 (6.4316)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Platelets Collected and Stored in InterSol, Control Platelets Collected and Stored in Plasma
	Comments	The null hypothesis is that P-selection's mean difference, Test - 1.25 * Control, is greater or equal to 0, and the alternative is that the mean difference is less than 0.
	Type of Statistical Test	Non-Inferiority
	Comments	Lower value is considered to indicate better platelet quality. If the 97.5% upper limit of the confidence interval is less than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	12.314
	Confidence Interval	(1-Sided) 97.5%; to 13.981
	Parameter Dispersion	Type: Standard Deviation; Value: 6.0422
	Estimation Comments	Estimated from an ANCOVA with effects of treatment and subject nested within sequence.

8. Secondary Outcome

Title	Percent of Extent of Shape Change
Description	Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. Higher value is considered to indicate better platelet quality.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.

Arm/Group Title	Test Platelets Collected and Stored in InterSol	Control Platelets Collected and Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.	Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Measure Participants	60	60
Mean (Standard Deviation) [% of extent of shape change]	19.328 (6.1433)	27.962 (5.4495)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Platelets Collected and Stored in InterSol, Control Platelets Collected and Stored in Plasma
	Comments	The null hypothesis is that ESC's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.
	Type of Statistical Test	Non-Inferiority
	Comments	Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-3.042
	Confidence Interval	(1-Sided) 97.5%; -4.407 to
	Parameter Dispersion	Type: Standard Deviation; Value: 5.4220
	Estimation Comments	Estimated from an ANCOVA with effects of treatment and subject nested within sequence.

9. Secondary Outcome

Title	Percent of Platelets Exhibiting Hypotonic Shock Response
Description	Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.

Arm/Group Title	Test Platelets Collected and Stored in InterSol	Control Platelets Collected and Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.	Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Measure Participants	60	60
Mean (Standard Deviation) [% of hypotonic shock response]	37.038 (7.4719)	49.284 (11.4719)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Platelets Collected and Stored in InterSol, Control Platelets Collected and Stored in Plasma
	Comments	The null hypothesis is that HSR's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.
	Type of Statistical Test	Non-Inferiority
	Comments	Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.389
	Confidence Interval	(1-Sided) 97.5%; -4.915 to
	Parameter Dispersion	Type: Standard Deviation; Value: 9.0544
	Estimation Comments	Estimated from an ANCOVA with effects of treatment and subject nested within sequence.

10. Secondary Outcome

Title	Platelet Morphology
Description	Quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher values represent healthier platelets.
Time Frame	Day 7

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria.

Arm/Group Title	Test Platelets Collected and Stored in InterSol	Control Platelets Collected and Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.	Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
Measure Participants	60	60
Mean (Standard Deviation) [score on a scale]	269.7 (31.26)	282.5 (34.79)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Platelets Collected and Stored in InterSol, Control Platelets Collected and Stored in Plasma
	Comments	The null hypothesis is that Morphology's mean difference, Test - 0.8 * Control, is less than or equal to 0, and the alternative is that the mean difference is greater than 0.
	Type of Statistical Test	Non-Inferiority
	Comments	Higher value is considered to indicate better platelet quality. If the 97.5% lower limit of the confidence interval is greater than 0, the null hypothesis will be rejected in favor of the alternative suggesting the Test product is not inferior to the Control product.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	43.8
	Confidence Interval	(1-Sided) 97.5%; 36.821 to
	Parameter Dispersion	Type: Standard Deviation; Value: 26.05
	Estimation Comments	Estimated from an ANCOVA with effects of treatment and subject nested within sequence.

Adverse Events

Time Frame	Treatment emergent adverse events were reported for any participant that underwent any study related apheresis procedure. Only adverse events that occured during the apheresis procedure and until discharge were reported.
Arm/Group Title	Test Platelets Collected and Stored in InterSol		Control Platelets Collected and Stored in Plasma
Arm/Group Description	Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.		Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
All Cause Mortality
	Test Platelets Collected and Stored in InterSol		Control Platelets Collected and Stored in Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/77 (0%)
Serious Adverse Events
	Test Platelets Collected and Stored in InterSol		Control Platelets Collected and Stored in Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/82 (0%)		0/77 (0%)
Other (Not Including Serious) Adverse Events
	Test Platelets Collected and Stored in InterSol		Control Platelets Collected and Stored in Plasma
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/82 (11%)		2/77 (2.6%)
General disorders
Injection site extravasation	7/82 (8.5%)	7	0/77 (0%)	0
Nervous system disorders
Paraesthesia oral	2/82 (2.4%)	2	1/77 (1.3%)	1
Dizziness	0/82 (0%)	0	1/77 (1.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor retains the right to review and comment on any public disclosure of study results. If no response is received within 30 days,the Principal Investigator may presume that the submission for publication may proceed without delay. If the Sponsor asks to defer publication, Study Site shall not publish, or otherwise disclose to any third party, any of the information contained in the publication or presentation until such time as permission is granted from the Sponsor.