Clinical Trial

Reversal of Antiplatelet Therapy with Cold Stored Platelets

Study Description

Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets

This study aims to determine whether cold-stored platelets (CSP) are equally, more effective, or uniquely effective at reversing the effect of dual antiplatelet therapy in healthy human subjects compared to room-temperature-stored platelets (RTP). The investigators plan to enroll healthy human subjects without risk factors for bleeding to achieve 60 complete data sets. Each subject will donate two apheresis platelet units. One platelet unit will be stored in the cold (CSP) and one platelet unit will be stored at room temperature (RTP). Subjects will be given dual anti-platelet therapy (aspirin and clopidogrel) prior to autologous transfusion of each unit. Platelet function testing will be performed before and after transfusion to measure reversal of the antiplatelet drugs.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - Autologous Platelet Transfusion (room-temperature-stored)

The participant will receive an autologous platelet transfusion of their room-temperature-stored platelets after 5 days of storage.

Drug - Autologous Platelet Transfusion (cold-stored 5 days)

The participant will receive an autologous platelet transfusion of their cold-stored platelets after 5 days of storage.

Drug - Autologous Platelet Transfusion (cold-stored 10 days)

The participant will receive an autologous platelet transfusion of their cold-stored platelets after 10 days of storage.

Drug - Autologous Platelet Transfusion (cold-stored 15 days)

The participant will receive an autologous platelet transfusion of their cold-stored platelets after 15 days of storage.

Drug - Aspirin

Aspirin (325mg) will be administered the day before every transfusion.

Drug - Clopidogrel

Clopidogrel (600mg) will be administered the day before every transfusion.

Additional Information

Official Study Title

Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets

Clinical Trial ID

NCT03787927

ParticipAid ID

e5y3xe