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

NCT02330081 | Completed Results

• 1 other identifier: CTS-0081
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

A total of twelve healthy volunteers will donate one unit of fresh whole blood. This unit will be treated with the Mirasol Pathogen Reduction Technology for Whole blood and then stored for 24h. At the end of storage, platelet concentrates will be separated from the unit, tested for key in vitro parameters and radiolabeled. On the same day (so 24h after the donation of whole blood), the volunteer will donate a fresh sample of whole blood. Platelets will be separated from this fresh sample and labeled with another radio-isotope. Then, the two radiolabeled platelet aliquots will be infused simultaneously and the recovery and survival of the two types of platelets will be measured.

Conditions

Blood Safety

Keywords

pathogen reduction technology; whole blood; Platelets; Mirasol

Outcome Measures

Primary Outcomes (2)

• Platelet 24-hour Relative Recovery

  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.

  24 hours

• Relative Platelet Survival

  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.

  Days 1 through 10 post-infusion

Secondary Outcomes (12)

• in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin

  Day 0 post-collection, day 0 post-illumination, day 1 post-storage

• in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit

  Day 0 post-collection, day 0 post-illumination, day 1 post-storage

• in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells

  Day 0 post-collection, day 0 post-illumination, day 1 post-storage

• in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets

  Day 0 post-collection, day 0 post-illumination, day 1 post-storage

• in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pH

  Day 0 post-collection, day 0 post-illumination, day 1 post-storage

Study Arms (1)

Mirasol

EXPERIMENTAL

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.

Device: Mirasol treatment of whole blood

Interventions

Mirasol treatment of whole blood DEVICE

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.

Also known as: Mirasol pathogen reduction system, Mirasol system for whole blood

Mirasol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 and \< 70 years
• Able to commit to the study follow-up schedule.
• Subjects must have adequate antecubital venous access for whole blood collection and follow-up blood draws.
• Subjects of child-bearing potential (female or male) must agree to use effective contraception per site guideline or abstain from heterosexual intercourse during the course of the study.
• Female of childbearing potential must be willing to take a pregnancy test prior to infusion of radiolabeled platelets.
• Subjects must agree to report adverse events (AEs) during the required reporting period.

You may not qualify if:

• Use of medications that interfere with platelet function within 48 hours of planned whole blood collection.
• Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical).
• Inability to comply with the protocol in the opinion of the investigator.
• Unable or unwilling to give informed consent.

Sponsors & Collaborators

• Terumo BCTbio: lead
• United States Department of Defense: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 2021, Norway

Location

Results Point of Contact

• Title: Beth Crump
• Organization: Terumo BCT

beth.crump@terumobct.com

+1 303 231-4606

Study Officials

• Ray Goodrich, PhD

  Terumo BCT VP Science, Clinical and Laboratory

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 1, 2015
• Study Start: April 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 12, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-05

Locations

NO (1)