Active — Not RecruitingPhase 4

Veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO) Heparin Study

United States100 participantsStarted 2018-10-10

Plain-language 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-venous extracorporeal membrane oxygenation for respiratory failure.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Incidence of bleeding complication

Timeframe: 1 week

Incidence of thrombotic complications requiring intervention

Timeframe: 1 week

Incidence of deep venous thrombosis

Timeframe: 1 week

Trial details

NCT IDNCT04496362

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-12

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