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Single Center Open Label Randomized Study Evaluating Safety and Efficacy of Subcutaneous Heparin Compared to Standard of Care Intravenous Heparin Anticoagulation During Veno-venous Extracorporeal Membrane Oxygenation for Respiratory Failure
This single-center, open-label study will evaluate the safety and efficacy of subcutaneous heparin anticoagulation compared to the standard of care systemic intravenous anticoagulation during veno-venous extracorporeal membrane oxygenation for respiratory failure.
Details
| Lead sponsor | Baylor Research Institute |
|---|---|
| Phase | Phase 4 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 100 |
| Start date | 2018-10-10 |
| Completion | 2026-06 |
Conditions
- ECMO
- Heparin
- Respiratory Failure
Interventions
- subcutaneous heparin anticoagulation
Primary outcomes
- Incidence of bleeding complication — 1 week
Safety will be assessed by incidence of bleeding complication (clinically apparent or need for blood transfusion without identified source) - Incidence of thrombotic complications requiring intervention — 1 week
Safety will be assessed by incidence of thrombotic complications requiring intervention (initiation of systemic anticoagulation or oxygenator exchange) - Incidence of deep venous thrombosis — 1 week
Incidence of deep venous thrombosis as assessed by four extremity venous ultrasound at one week post-decannulation
Countries
United States