NCT02754414

Cold Apheresis Platelets in PAS

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Bloodworks · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

A single hyperconcentrated 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. The platelet unit will be stored, not-agitated, for up to 20 days at 4°C in a suspension of 35% plasma and 65% PAS (Platelet Additive Solution). At the end of the storage period, the subject will return to receive an 111Indium Oxine (Indium 111, In-111) radiolabeled aliquot of their 4°C stored platelets. Follow-up samples from the subject will be collected approximately 2 hours post-infusion and on Days 1 (2X), 2 (2X), and 3 to calculate recovery and survival of the subject's 4°C stored platelets. The Day 1 and Day 2 the sample draws will be 2 - 10 hours apart. In addition to radiolabeled platelet recovery and survival measurements, various in vitro assays will be performed on the day of collection at the end of 4°C storage. One week after the infusion of the radiolabeled aliquot, the subject will return to receive a second radiolabeled aliquot of fresh platelets. To facilitate this, on the morning of the second infusion, the subject will return for collection of a 43 mL blood sample. The blood will be processed to obtain a fresh sample of the subject's platelets to serve as a control comparator. The platelets will be radiolabeled with In-111. The subject will return later in the day for infusion of the radiolabeled fresh 'control' comparator aliquot. Follow-up blood samples will be drawn at \~2 hours after the infusion on Day 0 and then on Days 1, 2, 3, 4 or 5, and 6 or 7 day post infusion to calculate recovery and survival of the subject's fresh vs. stored platelets.

Conditions

• Platelet Transfusion

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-12-01
• Completion: 2019-01-01
• First posted: 2016-04-28
• Last updated: 2018-05-14

Locations

1 site across 1 country: United States