N/A
N=22
Survival and Recovery of Radio-labeled Platelets Derived From Mirasol-treated Whole Blood
Blood Safety
Bottom Line
View on ClinicalTrials.gov: NCT02330081 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Platelet 24-hour Relative Recovery — 43.31; 52.01 Percentage of platelet count
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mirasol treatment of whole blood (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Terumo BCTbio
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Platelet 24-hour Relative Recovery |
43.31; 52.01 | — |
| PRIMARY Relative Platelet Survival |
152.9; 188.8 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemoglobin |
12.49; 11.69; 11.73 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hematocrit |
35.88; 33.37; 34.49 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - White Blood Cells |
4.49; 4.17; 3.64 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Platelets |
151.77; 110.52; 154.43 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pH |
7.017; 7.027; 6.804 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - CO2 |
9.96; 8.78; 13.05 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - pO2 |
5.93; 6.20; 4.68 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Potassium |
3.11; 3.10; 5.86 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Glucose |
20.50; 18.79; 15.12 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Lactate |
2.01; 2.44; 8.97 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Hemolysis |
0.1; 0.1; 0.2 | — |
| SECONDARY in Vitro Characteristics of Whole Blood and Platelets Derived From Mirasol-treated Whole Blood - Plasma Free Hemoglobin |
0.24; 0.22; 0.30 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy adult subjects, who meet the inclusion criteria defined by the Blood Center for whole blood donation.
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02330081). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.