Evaluation of Trima Version 7.0 Platelets in PAS
Sponsor
Terumo BCT (Industry)
Overall Status
Completed
CT.gov ID
NCT02754440
Collaborator
(none)
365
7
3
15.2
52.1
3.4
Study Details
Study Description
Brief Summary
To verify that platelets collected on the Trima Accel system with Version 7.0 software enhancements and stored in platelet additive solution (PAS) meet the FDA requirements for leukoreduction (< 5.0 × 10^6 residual white blood cells [WBC] per transfusable unit).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The study is designed to evaluate changes to the Trima Accel software to ensure the modified software meets the FDA acceptance criteria for leukoreduction and platelet yield. The operating range for the system flow rates, anticoagulant ratios, storage conditions, and centrifugal forces are the same as the currently cleared Trima Accel system. There are no changes to the environment or storage conditions for platelets, therefore, no in vitro or in vivo platelet quality data will be collected.
This is a prospective, open-label, multi-center controlled study to evaluate the leukoreduction of platelets stored in platelet additive solution (PAS) collected on the Trima Accel system Version 7.0 software enhancement. Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 single, 93 double and 93 triple platelet product evaluable data points. Evaluable is defined as a completed platelet product that does not meet any of the protocol analysis exclusion criteria.
Plateletpheresis will be per site standard practice and per applicable FDA guidelines such as the FDA Collection of Platelets by Automated Methods, December 2007 Guidance for Industry and Pre-storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion, September 2012.
Study participation will be up to 30 days and will consist of 1 to 2 visits. Screening may be done within 30 days before the apheresis procedure or combined as a single visit, which includes screening and the apheresis procedure all in 1 day.
The entire study should be completed in approximately 16 months.
Study Design
Study Type:
Interventional
Actual Enrollment
:
365 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of the Performance of Trima Accel® Version 7.0 Software Enhancements for the Collection of Platelets Stored in Platelet Additive Solution
Actual Study Start Date
:
Apr 20, 2016
Actual Primary Completion Date
:
Jul 28, 2017
Actual Study Completion Date
:
Jul 28, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Platelet Product Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. |
Device: Trima Accel System with Version 7.0 Software
Platelet Apheresis Procedure
|
| Experimental: Double Platelet Product Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. |
Device: Trima Accel System with Version 7.0 Software
Platelet Apheresis Procedure
|
| Experimental: Triple Platelet Product Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. |
Device: Trima Accel System with Version 7.0 Software
Platelet Apheresis Procedure
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level [Within 48 hours of end of donation]
The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level < 5.0 × 10^6; doubles = residual WBC level < 8.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit; and triples = residual WBC level < 12.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit.
Secondary Outcome Measures
- Number of Participants With Platelet Units Containing an Acceptable Platelet Yield [Within 48 hours of end of donation]
The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10^11 for singles, platelet yield ≥ 6.2 × 10^11 for doubles, and platelet yield ≥ 9.3 × 10^11 for triples.
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 or older.
-
Meets the inclusion criteria defined by the Blood Center for an apheresis platelet with PAS collection on the Trima Accel system. These criteria are based on FDA guidance and 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, as products are not transfused.
-
Has given written informed consent.
Exclusion Criteria:
- Has previously donated an evaluable platelet product in this study (CTS 5059).
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 |
| 3 | Indiana Blood Center | Indianapolis | Indiana | United States | 46208 |
| 4 | Memorial Blood Centers | Minneapolis | Minnesota | United States | 55114 |
| 5 | Community Blood Center of Greater Kansas | Kansas City | Missouri | United States | 64111-2390 |
| 6 | Hoxworth Blood Center | Cincinnati | Ohio | United States | 45267 |
| 7 | Blood Center of Wisconsin | Milwaukee | Wisconsin | United States | 53233 |
Sponsors and Collaborators
- Terumo BCT
Investigators
- Study Director: Heather Pidcoke, MD, PhD, Terumo BCT, Inc
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Terumo BCT
ClinicalTrials.gov Identifier:
NCT02754440
Other Study ID Numbers:
- CTS-5059
First Posted:
Apr 28, 2016
Last Update Posted:
May 11, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Study Results
Participant Flow
| Recruitment Details | A participant was considered "enrolled" upon signing the informed consent form. |
|---|---|
| Pre-assignment Detail | 365 participants consented/enrolled: 25 screen-failed; 5 never started procedure = 30 participants excluded from Safety Analysis. 335 participants = Safety Analysis set (56 participants excluded from the full analysis set: 35 participants were "unassigned" to an Arm, 21 participants were assigned to an Arm) 279 = Full Analysis set |
| Arm/Group Title | Single Platelet Product | Double Platelet Product | Triple Platelet Product | Unassigned |
|---|---|---|---|---|
| Arm/Group Description | Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis). |
| Period Title: Overall Study | ||||
| STARTED | 99 | 101 | 100 | 35 |
| COMPLETED | 93 | 93 | 93 | 0 |
| NOT COMPLETED | 6 | 8 | 7 | 35 |
Baseline Characteristics
| Arm/Group Title | Single Platelet Product | Double Platelet Product | Triple Platelet Product | Unassigned | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis). | Total of all reporting groups |
| Overall Participants | 99 | 101 | 100 | 35 | 335 |
| Age, Customized (Count of Participants) | |||||
| Age ≥ 18 years |
99
100%
|
101
100%
|
100
100%
|
35
100%
|
335
100%
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
43
43.4%
|
43
42.6%
|
43
43%
|
17
48.6%
|
146
43.6%
|
| Male |
56
56.6%
|
58
57.4%
|
57
57%
|
18
51.4%
|
189
56.4%
|
| Race/Ethnicity, Customized (Count of Participants) | |||||
| American Indian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
1%
|
2
2%
|
2
2%
|
0
0%
|
5
1.5%
|
| Black |
2
2%
|
3
3%
|
3
3%
|
2
5.7%
|
10
3%
|
| Hispanic |
1
1%
|
7
6.9%
|
6
6%
|
1
2.9%
|
15
4.5%
|
| White |
93
93.9%
|
86
85.1%
|
84
84%
|
28
80%
|
291
86.9%
|
| No Response |
0
0%
|
1
1%
|
2
2%
|
1
2.9%
|
4
1.2%
|
| Unknown |
1
1%
|
2
2%
|
0
0%
|
2
5.7%
|
5
1.5%
|
| Other |
1
1%
|
0
0%
|
3
3%
|
1
2.9%
|
5
1.5%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
99
100%
|
101
100%
|
100
100%
|
35
100%
|
335
100%
|
| Height (inches) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [inches] |
68.6
(3.90)
|
68.7
(3.95)
|
69.1
(4.04)
|
69.5
(4.28)
|
68.9
(3.99)
|
| Weight (pounds) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [pounds] |
202.25
(42.04)
|
205.09
(46.95)
|
225.01
(51.3)
|
207.45
(51.44)
|
210.44
(48.18)
|
Outcome Measures
| Title | Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level |
|---|---|
| Description | The number of participants with platelet units containing an acceptable residual WBC level. Acceptable residual WBC counts are: singles = residual WBC level < 5.0 × 10^6; doubles = residual WBC level < 8.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit; and triples = residual WBC level < 12.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit. |
| Time Frame | Within 48 hours of end of donation |
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 | Triple Platelet Product |
|---|---|---|---|
| Arm/Group Description | Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure |
| Measure Participants | 93 | 93 | 93 |
| Success (N) |
93
93.9%
|
93
92.1%
|
93
93%
|
| Failure (N) |
0
0%
|
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Single Platelet Product |
|---|---|---|
| Comments | Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure. | |
| Type of Statistical Test | Other | |
| Comments | A procedure is a success if the subject's platelet product has a residual WBC count of < 5.0 × 10^6 for the single platelet product group. The FDA requirements are met if the 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% 0.968 to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0 |
|
| Estimation Comments | When estimated proportion is 100%, standard error of the mean is estimated as 0. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Double Platelet Product |
|---|---|---|
| Comments | Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure. | |
| Type of Statistical Test | Other | |
| Comments | A procedure is a success if the subject's platelet product has a residual WBC count of < 8.0 × 10^6 for the double platelet product group, or < 5.0 × 10^6 for each transfusable unit . The FDA requirements are met if the 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% 0.968 to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0 |
|
| Estimation Comments | When estimated proportion is 100%, standard error of the mean is estimated as 0. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Triple Platelet Product |
|---|---|---|
| Comments | Up to 450 healthy adult subjects will be enrolled in this study to ensure 93 evaluable single platelet product collections, 93 evaluable double platelet product collections, and 93 evaluable triple platelet product collections. This number was chosen to meet the FDA requirements of at least 95% of platelet units with an acceptable residual WBC level with 95% confidence. With 93 platelet products, this allowed for at most 1 failure. | |
| Type of Statistical Test | Other | |
| Comments | A procedure is a success if the subject's platelet product has a residual WBC count of < 12.0 × 10^6 for the triple platelet product group, or < 5.0 × 10^6 for each transfusable unit . The FDA requirements are met if the 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% 0.968 to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0 |
|
| Estimation Comments | When estimated proportion is 100%, standard error of the mean is estimated as 0. | |
| Title | Number of Participants With Platelet Units Containing an Acceptable Platelet Yield |
|---|---|
| Description | The number of participants with platelet units containing an acceptable platelet yield. Acceptable platelet yield for single, double and triple platelet products are: platelet yield ≥ 3.0 × 10^11 for singles, platelet yield ≥ 6.2 × 10^11 for doubles, and platelet yield ≥ 9.3 × 10^11 for triples. |
| Time Frame | Within 48 hours of end of donation |
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 | Triple Platelet Product |
|---|---|---|---|
| Arm/Group Description | Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure |
| Measure Participants | 93 | 93 | 93 |
| Success (N) |
89
89.9%
|
93
92.1%
|
93
93%
|
| Failure (N) |
4
4%
|
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Single Platelet Product |
|---|---|---|
| Comments | Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence. | |
| Type of Statistical Test | Other | |
| Comments | A procedure is a success if the subject's platelet product has a platelet yield of ≥ 3.0 × 10^11 for the single platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Simple Sample Proportion |
| Estimated Value | 0.957 | |
| Confidence Interval |
(1-Sided) 95% 0.904 to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0.0210 |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Double Platelet Product |
|---|---|---|
| Comments | Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence. | |
| Type of Statistical Test | Other | |
| Comments | A procedure is a success if the subject's platelet product has a platelet yield of ≥ 6.2 × 10^11 for the double platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%. | |
| 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% 0.968 to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0 |
|
| Estimation Comments | When estimated proportion is 100%, standard error of the mean is estimated as 0. | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Triple Platelet Product |
|---|---|---|
| Comments | Up to 450 healthy subjects were enrolled to ensure 93 evaluable single, double, and triple platelet product collections. With 93 platelet products being collected, 16 failures or less was required to show that the proportion of units with an acceptable platelet yield is at least 75% with 95% confidence. | |
| Type of Statistical Test | Other | |
| Comments | A procedure is a success if the subject's platelet product has a platelet yield of ≥ 9.3 × 10^11 for the triple platelet product group. The requirements are met if the lower one-sided 95% confidence interval for the procedure success rate is at least 75%. | |
| 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% 0.968 to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 0 |
|
| Estimation Comments | When estimated proportion is 100%, standard error of the mean is estimated as 0. | |
Adverse Events
| Time Frame | Adverse events that occurred from the time of signing informed consent, through the screening period of up to 30 days, and on the day of the apheresis procedure were recorded. On the day of the apheresis procedure, adverse event monitoring stopped at the time participants left the blood center, which was considered study completion. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment begin with the apheresis venipuncture | |||||||
| Arm/Group Title | Single Platelet Product | Double Platelet Product | Triple Platelet Product | Unassigned | ||||
| Arm/Group Description | Healthy adult volunteer blood donors that qualify for a single unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Healthy adult volunteer blood donors that qualify for a double unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Healthy adult volunteer blood donors that qualify for a triple unit platelet collection will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System with Version 7.0 Software). Concurrent plasma will be collected in 25% of the collections. Trima Accel System with Version 7.0 Software: Platelet Apheresis Procedure | Participant and subsequent platelet product not assignable as single, double, triple (product not tested and/or was excluded from analysis). | ||||
All Cause Mortality |
||||||||
| Single Platelet Product | Double Platelet Product | Triple Platelet Product | Unassigned | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/99 (0%) | 0/101 (0%) | 0/100 (0%) | 0/35 (0%) | ||||
Serious Adverse Events |
||||||||
| Single Platelet Product | Double Platelet Product | Triple Platelet Product | Unassigned | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/99 (0%) | 0/101 (0%) | 0/100 (0%) | 0/35 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Single Platelet Product | Double Platelet Product | Triple Platelet Product | Unassigned | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/99 (10.1%) | 8/101 (7.9%) | 9/100 (9%) | 10/35 (28.6%) | ||||
| General disorders | ||||||||
| Injection Site Extravasation | 0/99 (0%) | 0 | 0/101 (0%) | 0 | 0/100 (0%) | 0 | 2/35 (5.7%) | 2 |
| Metabolism and nutrition disorders | ||||||||
| Citrate Toxicity | 10/99 (10.1%) | 10 | 8/101 (7.9%) | 8 | 9/100 (9%) | 9 | 0/35 (0%) | 0 |
| Vascular disorders | ||||||||
| Hematoma | 0/99 (0%) | 0 | 0/101 (0%) | 0 | 0/100 (0%) | 0 | 8/35 (22.9%) | 8 |
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.
Results Point of Contact
| Name/Title | Heather Pidcoke, MD, PhD |
|---|---|
| Organization | Terumo BCT, Inc. |
| Phone | (303) 231-4805 |
| Heather.Pidcoke@terumobct.com |
Responsible Party:
Terumo BCT
ClinicalTrials.gov Identifier:
NCT02754440
Other Study ID Numbers:
- CTS-5059
First Posted:
Apr 28, 2016
Last Update Posted:
May 11, 2018
Last Verified:
Apr 1, 2018