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

NCT ID: NCT02330081

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2015-07-31

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.

Detailed Description

The study will be a prospective, single-center, single-arm, intra-subject controlled, open-label design.

Subjects will donate one unit of fresh whole blood. This unit will be treated with the Mirasol PRT System for whole blood and then stored for 24 hours ± 1 hour at 22 ± 2°C. At the end of storage, platelet concentrates will be separated from the unit according to the Biomedical Excellence for Safer Transfusion (BEST) procedures. An aliquot will be removed from the platelet concentrates for testing and for radiolabeling and reinfusion. The platelets in Mirasol-treated whole blood will be tested for key in vitro parameters directly after treatment (Day 0) and at the end of storage (Day 1). Sterility testing will also be conducted on the stored units.

An aliquot of the platelet concentrate separated from each unit of stored Mirasol-treated whole blood will be radiolabeled with either 111Indium Oxine or 51Chromium, and autologously infused. An intra-subject control will be utilized as per the BEST guidelines for platelet radiolabeling procedures. On the day of infusion, the subject will donate a fresh sample of whole blood. Platelets will be separated from this fresh sample and labeled with the radio-isotope that was not used to label the subject's Mirasol-treated platelet sample. The two radiolabeled platelet aliquots (Mirasol-treated and fresh control) will be infused simultaneously, and the recovery and survival of the two types of platelets will be measured according to standard institutional practice.

Conditions

Blood Safety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mirasol treatment of whole blood

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Mirasol pathogen reduction system; Mirasol system for whole blood

Eligibility Criteria

Inclusion Criteria

2. Age ≥ 18 and < 70 years

3. Able to commit to the study follow-up schedule.

4. Subjects must have adequate antecubital venous access for whole blood collection and follow-up blood draws.

5. 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.

6. Female of childbearing potential must be willing to take a pregnancy test prior to infusion of radiolabeled platelets.

7. Subjects must agree to report adverse events (AEs) during the required reporting period.

Exclusion Criteria

1. Use of medications that interfere with platelet function within 48 hours of planned whole blood collection.

2. 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).

3. Inability to comply with the protocol in the opinion of the investigator.

4. Unable or unwilling to give informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Terumo BCTbio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ray Goodrich, PhD

Role: STUDY_CHAIR

Terumo BCT VP Science, Clinical and Laboratory

Locations

Haukeland University Hospital

Bergen, , Norway

Countries

Norway

Other Identifiers

CTS-0081

Identifier Type: -

Identifier Source: org_study_id