Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets

Summary

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.

Conditions

• Bleeding
• Platelet Dysfunction Due to Drugs
• Platelet Dysfunction

Interventions

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.

Sponsors & Collaborators

• National Blood Foundation

  collaborator UNKNOWN

• Bloodworks

  lead OTHER

Principal Investigators

• Moritz Stolla, MD · Bloodworks Northwest

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-12-03

Primary Completion

2021-12-03

Completion

2021-12-03

FDA Drug

Yes

Countries

• United States

Study Locations