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NCT06615492Recruiting

Routine vs On-demand ECMO for Lung Transplantation

RoutinE Versus On-demand Intraoperative Extracorporeal Membrane Oxygenation (ECMO) During LUng TransplantatION (REVOLUTION)

Source: ClinicalTrials.gov · Last updated 23 Dec 2025

Brief summary (registry, in English)

Lung transplantation is a complex procedure performed in patients with terminal lung disease. The transplant procedure stresses the patient's heart and lungs, which are already taxed by the underlying disease process. The heart-lung machine is occasionally used to support the patient and ensure adequate oxygen supply to other organs during the operation. It can be used routinely in all patients or selectively in patients who exhibit reduced oxygen supply to the remaining organs. This process, known as cardiopulmonary bypass (CPB), pumps blood out of the body to a heart-lung machine that removes carbon dioxide and returns oxygen-filled blood to the body. Although using the CPB increases the risk of bleeding, infection, and coagulation complications, it should still be considered in high-risk patients to compensate for more severe complications such as kidney failure and stroke caused by a lack of cardiopulmonary support. Extracorporeal membrane oxygenation (ECMO) is a recently developed CPB variation associated with fewer bleeding complications. It has recently replaced the traditional heart-lung machine as the preferred method of cardiopulmonary support during lung transplantation. Since ECMO is associated with fewer complications than standard CPB, many centers have increased their use of ECMO during lung transplantation. Some have even employed it routinely. However, there remains significant debate on how often it should be used. Therefore, the study's main objective is to compare the two approaches in lung transplantation, i.e., routine use versus selective use, and to determine if one approach is preferable to the other.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
218 (estimated)
First submitted
23 Sept 2024
Start date
5 Nov 2024
Primary completion date
5 Nov 2028
Lead sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Diseases
COPD
NCT number
NCT06615492

What you commit to

  • Study type: Interventional
  • Planned participants: 218
  • From 5 Nov 2024 to the primary completion date, 5 Nov 2028
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Multi-organ transplantation
  • Lung transplant recipients where intraoperative cardiopulmonary support is mandatory:
  • Patients requiring concomitant cardiac surgery: For example, significant coronary artery disease (CAD) requiring surgical grafting

Other illness

  • Severe pulmonary hypertension (PH):
    • Systolic pulmonary artery pressure (PAP) ≥ 80 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
    • Mean PAP ≥ 55 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
    • The ratio of mean pulmonary to systemic artery pressure of \> 0.66

Lab values

  • Left ventricular dysfunction: Defined as ejection fraction (LVEF) less than 45% on echocardiography, ventriculography, computed tomography (CT), or magnetic resonance imaging (MRI)

Other

  • Inability to provide consent for the study
  • Retransplantation
  • Contra-indication to standard heparin anticoagulation (e.g., heparin-induced thrombocytopenia)
  • Moderate to severe right ventricular (RV) hypokinesis or dysfunction

Who the study is looking for

  • Patients undergoing lung transplant surgery

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Univeristy of Alberta & Alberta Health Services
Coordinator of this site? Confirm its status
EdmontonCanadaNot yet recruiting
Centre Hospitalier de l'Université de Montréal
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
University Health Network / Toronto General Hospiatl
Coordinator of this site? Confirm its status
TorontoCanadaNot yet recruiting
Vancouver General Hospital
Coordinator of this site? Confirm its status
VancouverCanadaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.