Trial Outcomes & Findings for In Vivo Recovery and Survival Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution (NCT NCT03097289)

Last Updated: 2018-12-19

Results Overview

The percent recovery of platelets stored in InterSol for 5 Days as compared to fresh controls. Percent recovery was expressed as a percentage and was extrapolated for a value at Time 0. The FDA acceptance criteria for recovery is \>66% of control with a 1-sided 97.5% confidence limit.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

11 days (+/- 1 day)

Results posted on

2018-12-19

Participant Flow

A participant was considered "enrolled" upon signing the informed consent form.

33 participants consented/enrolled: 1 screen-failed; 32 participants started an apheresis procedure and were therefore included in the Safety Analysis Set 6 participants did not complete all study procedures, resulting in 26 participants completing the study; 2 participants met the Full Analysis set exclusion criteria 24 = Full Analysis set

Participant milestones

Participant milestones
Measure	Platelets Stored in InterSol Healthy adult volunteer blood donors will undergo apheresis for a single hyperconcentrated platelet product. Platelets will be stored in 65% InterSol/35% plasma for 5 days. Following storage for 5 days, an aliquot of Test platelets will be radiolabeled with either 111In or 51Cr. Similarly an aliquot of freshly prepared platelets derived from a whole blood sample donated on Day 5 (Control) will be tagged with the radiolabel not used in the Test platelets. The labeled aliquots will then be infused simultaneously on Day 5 back to the autologous donor.
Overall Study STARTED	32
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Platelets Stored in InterSol Healthy adult volunteer blood donors will undergo apheresis for a single hyperconcentrated platelet product. Platelets will be stored in 65% InterSol/35% plasma for 5 days. Following storage for 5 days, an aliquot of Test platelets will be radiolabeled with either 111In or 51Cr. Similarly an aliquot of freshly prepared platelets derived from a whole blood sample donated on Day 5 (Control) will be tagged with the radiolabel not used in the Test platelets. The labeled aliquots will then be infused simultaneously on Day 5 back to the autologous donor.
Overall Study Adverse Event	1
Overall Study Equipment failure	2
Overall Study Collected platelet product unusable	3

Baseline Characteristics

In Vivo Recovery and Survival Study of Platelets Collected on Trima Accel System and Stored in InterSol Solution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Platelets Stored in InterSol n=32 Participants Healthy adult volunteer blood donors will undergo apheresis for a single hyperconcentrated platelet product. Platelets will be stored in 65% InterSol/35% plasma for 5 days. Following storage for 5 days, an aliquot of Test platelets will be radiolabeled with either 111In or 51Cr. Similarly an aliquot of freshly prepared platelets derived from a whole blood sample donated on Day 5 (Control) will be tagged with the radiolabel not used in the Test platelets. The labeled aliquots will then be infused simultaneously on Day 5 back to the autologous donor.
Age, Customized Age ≥ 18 years	32 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	31 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants
Height	68.3 inches STANDARD_DEVIATION 3.24 • n=5 Participants
Weight	196.5 pounds STANDARD_DEVIATION 48.27 • n=5 Participants

PRIMARY outcome

Timeframe: 11 days (+/- 1 day)

Population: The Full Analysis Set (FAS) consisted of all completed procedures/products where the corresponding Test and Control values for primary endpoint were valid. Data points could be excluded from FAS if: 1. Primary endpoint laboratory samples were lost/not available 2. Failure of site to follow post-collection handling procedures for endpoint assays

Outcome measures

Outcome measures
Measure	Test Platelets Collected and Stored in InterSol n=24 Participants Platelets stored in InterSol One Test unit will be collected as a hyperconcentrated platelet product. The Test unit will be diluted to a final ratio of 65% InterSol/35% plasma and stored for 5 days.	Control Platelets n=24 Participants Control Platelets An aliquot of freshly prepared platelets derived from a whole blood sample.
Recovered Percentage of the Extrapolated Platelet Count at Time 0	45.15 percent of extrapolated platelet count Standard Deviation 12.256	56.02 percent of extrapolated platelet count Standard Deviation 13.162

PRIMARY outcome

Timeframe: 11 days (+/- 1 day)

Survival of platelets stored in InterSol for 5 Days as compared to fresh controls. Survival was expressed in days and was approximated using linear regression. The FDA acceptance criteria for survival is \>58% of control with a 1-sided 97.5% confidence limit

Outcome measures

Outcome measures
Measure	Test Platelets Collected and Stored in InterSol n=24 Participants Platelets stored in InterSol One Test unit will be collected as a hyperconcentrated platelet product. The Test unit will be diluted to a final ratio of 65% InterSol/35% plasma and stored for 5 days.	Control Platelets n=24 Participants Control Platelets An aliquot of freshly prepared platelets derived from a whole blood sample.
Number of Days of Platelet Survival	5.40 days Standard Deviation 0.991	7.93 days Standard Deviation 1.483

Adverse Events

Platelets Stored in InterSol

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Platelets Stored in InterSol n=32 participants at risk Healthy adult volunteer blood donors will undergo apheresis for a single hyperconcentrated platelet product. Platelets will be stored in 65% InterSol/35% plasma for 5 days. Following storage for 5 days, an aliquot of Test platelets will be radiolabeled with either 111In or 51Cr. Similarly an aliquot of freshly prepared platelets derived from a whole blood sample donated on Day 5 (Control) will be tagged with the radiolabel not used in the Test platelets. The labeled aliquots will then be infused simultaneously on Day 5 back to the autologous donor.
General disorders Injection site extravasation	12.5% 4/32 • Adverse events that occurred on or after the start of the apheresis procedure (time of venipuncture) until study completion (16 days +/- 1 day). Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment began with the apheresis venipuncture.
Nervous system disorders Paraesthesia oral	6.2% 2/32 • Adverse events that occurred on or after the start of the apheresis procedure (time of venipuncture) until study completion (16 days +/- 1 day). Treatment emergent adverse events were analyzed in the Safety Analysis set. Treatment began with the apheresis venipuncture.

Additional Information

Ned Cosgriff, MD

Terumo BCT, Inc.

Phone: +1 303-239-2316

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor retains the right to review and comment on any public disclosure of study results. If no response is received within 60 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 expiration of the 60 day period.
Publication restrictions are in place

Restriction type: OTHER