Anticoagulation-free VV ECMO for Acute Respiratory Failure

• Status: Not yet recruiting
• Trial end date: 2021-08-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damian Ratano
• Collaborator: The Physicians' Services Incorporated (PSI) Foundation
• Treatments: Calcium heparin; Enoxaparin; Heparin

Criteria

Inclusion Criteria:

• Adult patient with ARDS on VV-ECMO

Exclusion Criteria:

• 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)