Anticoagulation-free VV ECMO for Acute Respiratory Failure

Last updated: August 19, 2022
Sponsor: Damian Ratano
Overall Status: Active - Recruiting

Phase

2/3

Condition

Respiratory Failure

Lung Injury

Treatment

N/A

Clinical Study ID

NCT04273607
19-5692.0
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adult patient with ARDS on VV-ECMO

Exclusion

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 veinthrombosis, chronic anticoagulation therapy before ECMO insertion)
  • Low-flow (<2 liters/min) VV-ECMO (ECCO2R)

Study Design

Total Participants: 40
Study Start date:
September 01, 2022
Estimated Completion Date:
June 30, 2024

Study Description

Although anticoagulation targets and monitoring strategies vary around the world, the current practice is still to anticoagulate patients on ECMO, mostly with UFH. However, the use of heparin coated circuits has changed their thrombogenicity. Preliminary data suggest that a low-dose unfractionated heparin (UFH) strategy is non-inferior to a therapeutic dose UFH. Indeed, in daily practice, when a patient on ECMO has severe bleeding complications, UFH is often stopped until the hemorrhagic issue is under control, sometimes for days. This has led some to hypothesize that anticoagulation might not be necessary for VV-ECMO, and a few case series report little to no increase in adverse events as a result. There are currently no randomized controlled trials comparing anticoagulation to no anticoagulation for patients supported with ECMO. Anticoagulation is, for physiological reasons, less necessary during VV-ECMO than VA-ECMO and this is the reason why our pilot study will focus on VV-ECMO only. Whereas the whole ECMO device is identical for both configurations, the risk of systemic embolization (e.g., stroke) and its severe complications is much higher in VA-ECMO where blood is reinjected directly into the systemic arterial system. Moreover, in the presence of severely decreased left ventricular function requiring VA-ECMO, the risk of left ventricular thrombus is very high and requires anticoagulation. During VV-ECMO, the risk of systemic embolization is low because the whole circuit is on the right side of the heart and relatively preserved biventricular function is needed to perform VV-ECMO

The hypothesis is that VV-ECMO is safe and feasible without therapeutic anticoagulation for adults with ARDS.

The objectives of this study is to assess, through a pilot study, the safety and feasibility of an "anticoagulation free strategy" for veno-venous ECMO (VV-ECMO) in acute respiratory failure

Connect with a study center

  • Toronto General Hospital

    Toronto, Ontario M5G 2N2
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.