RecruitingPhase 2Phase 3NCT04273607

Anticoagulation-free VV ECMO for Acute Respiratory Failure

Anticoagulation-free VV ECMO for Acute Respiratory Failure: A Pilot Safety and Feasibility Randomized Clinical Trial


Sponsor

Damian Ratano

Enrollment

40 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Currently international experts recommend therapeutic anticoagulation for veno-venous extracorporeal membrane oxygenation (VV-ECMO). Reports and case series suggest that the absence of therapeutic anticoagulation is safe for VV-ECMO. No randomized control trials have assessed this. The aim of this pilot study is to assess safety and feasibility of an "anticoagulation-free strategy" for veno-venous ECMO (VV-ECMO) in Acute respiratory distress syndrome (ARDS).


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Adult patient with ARDS on VV-ECMO

Exclusion Criteria3

  • Contraindication to anticoagulation with UFH (known heparin-induced thrombocytopenia, active hemorrhage, any surgery precluding the use of anticoagulation),
  • Indication for therapeutic anticoagulation (pulmonary embolism or deep vein thrombosis, chronic anticoagulation therapy before ECMO insertion)
  • Low-flow (\<2 liters/min) VV-ECMO (ECCO2R)

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Interventions

DRUGSubcutaneous Heparin

The intervention group will receive prophylactic heparin instead of standard of care therapeutic intravenous heparin


Locations(1)

Toronto General Hospital

Toronto, Ontario, Canada

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NCT04273607


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