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Assessment of Whole Blood Cold Stored Platelets

NCT02006368 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-08-04

No results posted yet for this study

Summary

The purpose of this study is to determine the life span and functional characteristics of platelets derived from whole blood that has been stored in a refrigerator for up to 21 days. Currently, platelets are separated from red cells shortly after donation and stored at room temperature for no longer than 5 days. This study is considered experimental because; 1) we will be keeping platelets in the original whole blood donor unit in the refrigerator, and 2) we will be reinfusing a small portion of that donation back into the study-subject-donor and tracking how many of the transfused platelets from that unit circulate in the study-subject-donor in the hours and days after transfusion.

Conditions

  • Healthy

Interventions

OTHER

Blood Collection and autologous re-infusion

Subjects will donate one unit of whole blood. This unit will be stored at 4°C for a predefined storage period. A variety of in vitro metabolic and functional platelet assays will be performed on the stored unit. After the storage period, an aliquot from the whole blood unit will be processed to obtain platelets. The subject will return and donate a fresh sample of whole blood (43 mls) from which a fresh aliquot of platelets will be obtained. The stored and fresh platelets will each be labeled with a different radioisotope (either Chromium-51 or Indium-111) and reinfused into the subject. Using two different radioisotopes enables separate tracking of both the stored and fresh platelets. Follow-up blood samples will be drawn at 2 hours and on days 1, 2, 3, 5, 7±1 and 10±2. Stored and Fresh platelet recoveries and survivals will be calculated.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Bloodworks

    lead OTHER

Principal Investigators

  • Sherrill J Slichter, MD · Puget Sound Blood Center & University of Washington

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02006368 on ClinicalTrials.gov