Trial Outcomes & Findings for Trima Accel® System Post Count Algorithm Study (NCT NCT02684630)

Last Updated: 2017-07-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

131 participants

Primary outcome timeframe

The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis

Results posted on

2017-07-12

Participant Flow

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

Participant milestones

Participant milestones
Measure	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 System. Trima Accel System: Platelet Apheresis Procedure	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 System. Trima Accel System: Platelet Apheresis Procedure
Overall Study STARTED	65	63
Overall Study COMPLETED	60	60
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trima Accel® System Post Count Algorithm Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Platelet Product n=65 Participants 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	Double Platelet Product n=63 Participants 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 n=128 Participants Total of all reporting groups
Age, Customized Age ≥ 18 years	65 Participants n=5 Participants	63 Participants n=7 Participants	128 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	17 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	46 Participants n=7 Participants	88 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized White	56 Participants n=5 Participants	53 Participants n=7 Participants	109 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Height (in)	68.9 inches STANDARD_DEVIATION 3.95 • n=5 Participants	69.0 inches STANDARD_DEVIATION 3.43 • n=7 Participants	69.0 inches STANDARD_DEVIATION 3.69 • n=5 Participants
Weight (lbs)	190.3 pounds STANDARD_DEVIATION 37.59 • n=5 Participants	191.6 pounds STANDARD_DEVIATION 31.23 • n=7 Participants	191.0 pounds STANDARD_DEVIATION 34.47 • n=5 Participants
Total Blood Volume (mL)	5214.3 mililiters STANDARD_DEVIATION 905.93 • n=5 Participants	5285.7 mililiters STANDARD_DEVIATION 735.86 • n=7 Participants	5249.5 mililiters STANDARD_DEVIATION 824.15 • n=5 Participants

PRIMARY outcome

Timeframe: The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis

Population: 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.

Outcome measures

Outcome measures
Measure	Single Platelet Product n=60 Participants 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	Double Platelet Product n=60 Participants 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
Donor Postprocedure Platelet Count Following Donation of Single Platelet Product Success (n)	60 Participants	60 Participants
Donor Postprocedure Platelet Count Following Donation of Single Platelet Product Failure (n)	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Single Platelet Product n=60 Participants 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	Double Platelet Product n=60 Participants 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
Donor Postprocedure Platelet Count Following Donation of Double Platelet Product Success (n)	60 Participants	60 Participants
Donor Postprocedure Platelet Count Following Donation of Double Platelet Product Failure (n)	0 Participants	0 Participants

Adverse Events

Single Platelet Product

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Double Platelet Product

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Single Platelet Product n=65 participants at risk 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	Double Platelet Product n=63 participants at risk 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
Metabolism and nutrition disorders Citrate Toxicity	3.1% 2/65 • Number of events 2 • Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.	0.00% 0/63 • Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.
Nervous system disorders Paraesthesia	3.1% 2/65 • Number of events 2 • Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.	1.6% 1/63 • Number of events 1 • Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.
Nervous system disorders Presyncope	0.00% 0/65 • Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.	1.6% 1/63 • Number of events 1 • Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.
General disorders Injection Site Extravasation	1.5% 1/65 • Number of events 1 • Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.	0.00% 0/63 • Adverse events that occurred during and up to 24 hours after the apheresis procedure were recorded.

Additional Information

Heather Pidcoke, MD, PhD

Terumo BCT, Inc.

Phone: (303) 231-4805

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place