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Cold Apheresis Platelets in PAS

NCT02754414 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-05-14

No results posted yet for this study

Summary

This is a platelet transfusion study. The purpose of this study is to measure the life span and quality of platelets stored in a refrigerator. Participants will give platelets by apheresis. Platelets will be stored for 3 -20 days. A small portion of the subject's own stored platelets will be tagged with a radioactive isotope and infused back into the participant. This will enable us to track how many transfused platelets survive after storage in the refrigerator.

Conditions

  • Platelet Transfusion

Interventions

PROCEDURE

Apheresis platelet collection

A single apheresis platelet unit will be collected from a healthy adult volunteer subject using the Trima Accel® Automated Blood Collection System. Concurrent plasma will be collected.

OTHER

Refrigerated storage of apheresis platelets in PAS/plasma

The apheresis platelet unit will be stored, without agitation, at 4°C, for up to 20 days.

RADIATION

Infusion of aliquot of autologous radiolabeled platelets

Fresh and stored aliquots will be labeled with Indium-111. We are administering ≤30 microcuries in both infusions for a total dose of 0.8 mSv.

OTHER

In vitro tests

Tests to evaluate platelet function will be performed on the platelet unit on day of collection and end of storage

Sponsors & Collaborators

  • Bloodworks

    lead OTHER

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
2016-04-30
Primary Completion
2018-12-31
Completion
2019-01-31

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 NCT02754414 on ClinicalTrials.gov