Trial Outcomes & Findings for Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood (NCT NCT02330081)

Results Overview

Relative recovery of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC, measured as a percentage of platelets derived from freshly collected WB from the same participant. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

24 hours

Results posted on

2019-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Mirasol Subject will be infused with two products at the same time: 1. radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subjects untreated fresh whole blood. Mirasol treatment of whole blood: Subject will be infused with two products at the same time: 1. radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subject's untreated fresh whole blood.
Overall Study STARTED	22
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Mirasol Subject will be infused with two products at the same time: 1. radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subjects untreated fresh whole blood. Mirasol treatment of whole blood: Subject will be infused with two products at the same time: 1. radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subject's untreated fresh whole blood.
Overall Study Adverse Event	1
Overall Study Donation did not meet criteria	1
Overall Study Protocol Violation	6

Baseline Characteristics

Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirasol n=14 Participants Subject will be infused with two products at the same time: 1. radio-labeled platelets derived from subjects stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subjects untreated fresh whole blood. Mirasol treatment of whole blood: Subject will be infused with two products at the same time: 1. radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol. 2. radio-labeled platelets derived from subject's untreated fresh whole blood.
Age, Continuous	40.4 years STANDARD_DEVIATION 11.94 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Norway	14 participants n=5 Participants
Height	172.6 cm STANDARD_DEVIATION 9.08 • n=5 Participants
Weight	78.7 kg STANDARD_DEVIATION 13.68 • n=5 Participants
Blood type A	6 participants n=5 Participants
Blood type B	1 participants n=5 Participants
Blood type AB	0 participants n=5 Participants
Blood type O	7 participants n=5 Participants
Rhesus status Positive	14 participants n=5 Participants
Rhesus status Negative	0 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: Per Protocol Population = all subjects in the mITT Population who met all of the inclusion and none of the exclusion criteria at enrollment, had no concurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had completed all postinfusion blood sampling for recovery and survival calculations and had no protocol violations.

Relative recovery of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC, measured as a percentage of platelets derived from freshly collected WB from the same participant. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.

Outcome measures

Outcome measures
Measure	Test Platelets From Mirasol-treated Whole Blood n=14 Participants Mirasol-treated platelets: Platelets were collected from 1 Test unit of whole blood that had been treated with the Mirasol pathogen reduction process and stored for 24 hours.	Control Platelets n=14 Participants Control platelets: An aliquot of platelets derived from a freshly collected whole blood sample
Platelet 24-hour Relative Recovery	43.31 Percentage of platelet count Interval 37.93 to 48.69	52.01 Percentage of platelet count Interval 45.22 to 58.8

PRIMARY outcome

Timeframe: Days 1 through 10 post-infusion

Population: Per Protocol Population = all subjects in the mITT Population who met all of the inclusion and none of the exclusion criteria at enrollment, had no concurrent illness or notable signs/symptoms during the 24 hours prior to reinfusion, had completed all postinfusion blood sampling for recovery and survival calculations and had no protocol violations.

Mean survival time of platelets derived from Mirasol-treated whole blood (WB) units that had been stored for 24 ± 1 hours at 22 ± 2ºC as compared to the mean survival time of fresh platelets from the same donor, measured in hours. Platelets were isolated from both Mirasol-treated WB and from fresh WB from the same participant, radiolabeled with either 111Indium or 51Chromium, and these 2 radiolabeled platelet samples (ie, 1 untreated, fresh and 1 Mirasol-treated, stored) were combined and reinfused back to the same participant.