Trials / Unknown
UnknownNCT03787927
Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Bloodworks · Academic / Other
- Sex
- All
- Age
- 18 Years – 59 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-12-03
- Primary completion
- 2021-12-03
- Completion
- 2021-12-03
- First posted
- 2018-12-27
- Last updated
- 2020-07-14
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03787927. Inclusion in this directory is not an endorsement.