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NCT03787927: R-DAPT
Reversal of Dual Antiplatelet Therapy With Cold Stored Platelets
Phase 1, PHASE2 trial testing Autologous Platelet Transfusion (room-temperature-stored) in Bleeding in 60 participants. Status unknown.
3 December 2021
Quick facts
| Lead sponsor | Bloodworks |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 3 December 2018 |
| Primary completion | 3 December 2021 |
| Estimated completion | 3 December 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Autologous Platelet Transfusion (room-temperature-stored) — full drug profile →
- Autologous Platelet Transfusion (cold-stored 5 days) — full drug profile →
- Autologous Platelet Transfusion (cold-stored 10 days) — full drug profile →
- Autologous Platelet Transfusion (cold-stored 15 days) — full drug profile →
- Aspirin
- Clopidogrel (clopidogrel) — full drug profile →
Conditions studied
- Bleeding — all drugs for Bleeding →
- Platelet Dysfunction Due to Drugs — all drugs for Platelet Dysfunction Due to Drugs →
- Platelet Dysfunction — all drugs for Platelet Dysfunction →
Sponsor
Bloodworks — full company profile →
Who can join
Adults 18 to 59, any sex, with Bleeding or Platelet Dysfunction Due to Drugs. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03787927
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Bloodworks trials
Trials by the same sponsor.
- NCT07513532 — The Primary Purpose of This Study is to Determine if Biotin, Vitamin B7 is an Effective Way to Label Platelets in Surviv · Phase 1 · not yet recruiting
- NCT03358836 — Joint Health Study · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03787927 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bloodworks
- Last refreshed: 14 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03787927.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing