Status:
RECRUITING
Veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO) Heparin Study
Lead Sponsor:
Baylor Research Institute
Conditions:
ECMO
Heparin
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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-ven...
Detailed Description
Extracorporeal membrane oxygenation (ECMO) has been increasing used over the past decade as supportive therapy in patients with respiratory failure, in order to avoid life-threatening hypoxemia, in ca...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years of age
- Respiratory failure requiring VV-ECMO support
- Subject or appointed health care proxy/LAR is able to understand and sign the informed consent form
Exclusion
- Subject currently enrolled in another interventional research trial
- History of hypersensitivity/adverse reaction to heparin
- Proven Heparin induced thrombocytopenia (HIT)
- History of patent foramen ovale (PFO)
- Recent surgery or other contraindication to systemic anticoagulation, e.g. intracranial bleed
- Medical indication other than ECMO for systemic anticoagulation, e.g. pulmonary embolism
Key Trial Info
Start Date :
October 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04496362
Start Date
October 10 2018
End Date
December 1 2026
Last Update
October 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Baylor Scott & White Health research institute
Dallas, Texas, United States, 75246