Trima Accel® System Post Count Algorithm Study

• Sponsor: Terumo BCT (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02684630
• Collaborator: (none)
• Enrollment: 131
• Locations: 2
• Arms: 2
• Duration (Months): 4
• Patients Per Site: 65.5
• Patients Per Site Per Month: 16.5

Study Details

Study Description

Brief Summary

The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of >100,000/µL.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Device: Trima Accel System	N/A

Detailed Description

This is a prospective, open-label, non-randomized study to evaluate Trima Accel System modified postcount algorithm software.

Platelets will be collected according to the Trima Accel System Operator's Manual. Collection procedures will include those in which:

1. a single platelet product is collected

2. a double platelet product is collected, with or without other components.

Study participation will be up to 8 days. The apheresis procedure can last from 25 to 150 minutes, dependent upon the product(s) to be collected, machine configuration, donor parameters, the quality of the vascular access, and the tolerance of the donor to the citrate anticoagulant.

Donors will have one apheresis procedure and follow-up with any serious adverse events for 7 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 131 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Multicenter Study to Evaluate Modified Postcount Algorithm Software on the Trima Accel® System in Volunteer Blood Donors
• Study Start Date: Jan 28, 2016
• Actual Primary Completion Date: May 28, 2016
• Actual Study Completion Date: May 28, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Platelet Product Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).	Device: Trima Accel System; Platelet Apheresis Procedure
Experimental: Double Platelet Product Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).	Device: Trima Accel System; Platelet Apheresis Procedure

Outcome Measures

Primary Outcome Measures

1. Donor Postprocedure Platelet Count Following Donation of Single Platelet Product [The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis]

   The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was < 100,000 platelets/μL.

2. Donor Postprocedure Platelet Count Following Donation of Double Platelet Product [The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis]

   The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL.

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.

• Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines.

• Appears to have adequate venous access to obtain a postprocedure platelet count.

• Has given written informed consent.

Exclusion Criteria:

• Has undergone a splenectomy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Diego Blood Bank	San Diego	California	United States	92102
2	Bonfils Blood Center	Denver	Colorado	United States	80230

Sponsors and Collaborators

• Terumo BCT

Investigators

• Study Director: Heather Pidcoke, MD, PhD, Terumo BCT, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Terumo BCT
• ClinicalTrials.gov Identifier: NCT02684630
• Other Study ID Numbers: CTS-5054
• First Posted: Feb 18, 2016
• Last Update Posted: Jul 12, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Pre-assignment Detail	131 volunteers signed consent and were enrolled, but 3 were screen fails and therefore did not participate in the study

Arm/Group Title	Single Platelet Product	Double Platelet Product
Arm/Group Description	Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System. Trima Accel System: Platelet Apheresis Procedure	Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System. Trima Accel System: Platelet Apheresis Procedure
Period Title: Overall Study
STARTED	65	63
COMPLETED	60	60
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Single Platelet Product	Double Platelet Product	Total
Arm/Group Description	Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System. Trima Accel System: Platelet Apheresis Procedure	Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System. Trima Accel System: Platelet Apheresis Procedure	Total of all reporting groups
Overall Participants	65	63	128
Age, Customized (Count of Participants)
Age ≥ 18 years	65 100%	63 100%	128 100%
Sex: Female, Male (Count of Participants)
Female	23 35.4%	17 27%	40 31.3%
Male	42 64.6%	46 73%	88 68.8%
Race/Ethnicity, Customized (Count of Participants)
Asian	1 1.5%	2 3.2%	3 2.3%
Black	2 3.1%	2 3.2%	4 3.1%
Hispanic	3 4.6%	5 7.9%	8 6.3%
White	56 86.2%	53 84.1%	109 85.2%
Other	1 1.5%	1 1.6%	2 1.6%
Unknown	2 3.1%	0 0%	2 1.6%
Height (in) (inches) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [inches]	68.9 (3.95)	69.0 (3.43)	69.0 (3.69)
Weight (lbs) (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	190.3 (37.59)	191.6 (31.23)	191.0 (34.47)
Total Blood Volume (mL) (mililiters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mililiters]	5214.3 (905.93)	5285.7 (735.86)	5249.5 (824.15)

Outcome Measures

1. Primary Outcome

Title	Donor Postprocedure Platelet Count Following Donation of Single Platelet Product
Description	The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was < 100,000 platelets/μL.
Time Frame	The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.

Arm/Group Title	Single Platelet Product	Double Platelet Product
Arm/Group Description	Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). Trima Accel System: Platelet Apheresis Procedure	Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). Trima Accel System: Platelet Apheresis Procedure
Measure Participants	60	60
Success (n)	60 92.3%	60 95.2%
Failure (n)	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Single Platelet Product
	Comments	Sample Size Determination: Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence.
	Type of Statistical Test	Other
	Comments	A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Simple sample proportion
	Estimated Value	1.00
	Confidence Interval	(1-Sided) 95%; 0.951 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	Donor Postprocedure Platelet Count Following Donation of Double Platelet Product
Description	The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL.
Time Frame	The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis

Outcome Measure Data

Analysis Population Description

The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.

Arm/Group Title	Single Platelet Product	Double Platelet Product
Arm/Group Description	Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System. Trima Accel System: Platelet Apheresis Procedure	Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System. Trima Accel System: Platelet Apheresis Procedure
Measure Participants	60	60
Success (n)	60 92.3%	60 95.2%
Failure (n)	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Double Platelet Product
	Comments	Sample Size Determination: Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence.
	Type of Statistical Test	Other
	Comments	A procedure is a success if the donor's post-procedure platelet count is ≥ 100,000 platelets/μL, lower one-sided 95% confidence interval for the procedure success rate is at least 95%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Simple sample proportion
	Estimated Value	1.00
	Confidence Interval	(1-Sided) 95%; 0.951 to
	Parameter Dispersion	Type: Standard Deviation; Value: 0
	Estimation Comments	Estimated proportion is 100%. Hence standard deviation is estimated as 0.

Adverse Events

Time Frame	Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.
Arm/Group Title	Single Platelet Product		Double Platelet Product
Arm/Group Description	Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). Trima Accel System: Platelet Apheresis Procedure		Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System). Trima Accel System: Platelet Apheresis Procedure
All Cause Mortality
	Single Platelet Product		Double Platelet Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/63 (0%)
Serious Adverse Events
	Single Platelet Product		Double Platelet Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/65 (0%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	Single Platelet Product		Double Platelet Product
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/65 (7.7%)		2/63 (3.2%)
General disorders
Injection Site Extravasation	1/65 (1.5%)	1	0/63 (0%)	0
Metabolism and nutrition disorders
Citrate Toxicity	2/65 (3.1%)	2	0/63 (0%)	0
Nervous system disorders
Paraesthesia	2/65 (3.1%)	2	1/63 (1.6%)	1
Presyncope	0/65 (0%)	0	1/63 (1.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.