Recruiting
Phase 2
Phase 3

Anticoagulation-free VV ECMO

Sponsor:

Damian Ratano

Code:

NCT04273607

Conditions

Extracorporeal Membrane Oxygenation Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Subcutaneous Heparin

Study Details

Brief 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).

Conditions

Extracorporeal Membrane Oxygenation Complication

Study ID

NCT04273607

Start date

Sep 1, 2022

Status verified date

Jan, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: No anticoagulation

Participants in this arm will not receive unfractionated heparin during the course of ECMO. They will receive standard venous thromboembolism prophylaxis with subcutaneous enoxaparin or unfractionated heparin

no intervention: Anticoagulation, ECMO standard of care

Participants in this arm will receive the standard of care anticoagulation with unfractionated heparin during the course of ECMO.

Interventions

Subcutaneous Heparin

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

Primary outcome measure

  • ECMO associated thrombotic complications [ Time Frame: through ECMO completion, an average of 14 days ]

Central Contacts and Locations

Central contacts

Damian Ratano, MD

+1 416-340-3601damian.ratano@chuv.ch

Eddy Fan, MD, PhD

+1 416-340-3601eddy.fan@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Eddy Fan, MD-PhD

+ 1 416 340 3601eddy.fan@uhn.ca

More Information

Sponsor

Damian Ratano

Last update posted

Jan 16, 2026

Last verified

Jan, 2026

Keywords

  • Extracorporeal membrane oxygenation
  • Anticoagulation
  • Thrombosis
  • Hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Damian Ratano on 2026-01-16.