Routine versus on-demand ECMO during lung transplant

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

This trial tests whether using ECMO routinely during lung transplant or only when needed leads to fewer complications for people having a lung transplant.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 218 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) (Academic / other)
• Locations: 4 sites (Edmonton, Alberta and 3 other locations)
• Trial ID: NCT06615492 on ClinicalTrials.gov

What this trial studies

This is a prospective, randomized controlled trial comparing two intraoperative cardiopulmonary support strategies: routine use of extracorporeal membrane oxygenation (ECMO) for all lung transplants versus selective (on-demand) ECMO initiated only for hypoxia or hemodynamic instability. Eligible adults scheduled for lung transplantation are randomized to one of the two arms, with predefined exclusion criteria such as retransplantation, multi-organ transplant, severe pulmonary hypertension, significant ventricular dysfunction, or contraindication to heparin. The study will measure intraoperative stability and postoperative hypoperfusion-related complications using standardized perioperative protocols across participating centers. The trial is conducted at multiple Canadian lung transplant centers following uniform ECMO and follow-up procedures.

Who should consider this trial

Good fit: Adults scheduled for single or bilateral lung transplantation who can give consent and do not meet exclusions like retransplantation, multi-organ transplant, severe pulmonary hypertension, significant ventricular dysfunction, or contraindication to heparin are ideal candidates.

Not a fit: Patients who require mandatory cardiopulmonary support (for example severe pulmonary hypertension, moderate-to-severe RV dysfunction, or LVEF <45%), those undergoing retransplantation or multi-organ transplant, or those with contraindications to heparin anticoagulation are unlikely to benefit from randomization in this trial.

Why it matters

Potential benefit: If successful, routine intraoperative ECMO could reduce intraoperative instability and lower rates of postoperative complications related to organ hypoperfusion such as kidney injury and stroke.

How similar studies have performed: ECMO is widely used and observational series suggest benefits for intraoperative support, but randomized comparisons of routine versus on-demand intraoperative ECMO are limited.

Eligibility criteria

Inclusion Criteria:

* Patients undergoing lung transplant surgery

Exclusion Criteria:

* Inability to provide consent for the study
* Retransplantation
* Multi-organ transplantation
* Contra-indication to standard heparin anticoagulation (e.g., heparin-induced thrombocytopenia)
* Lung transplant recipients where intraoperative cardiopulmonary support is mandatory:
* Severe pulmonary hypertension (PH):

  1. Systolic pulmonary artery pressure (PAP) ≥ 80 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
  2. Mean PAP ≥ 55 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
  3. The ratio of mean pulmonary to systemic artery pressure of \> 0.66
* Moderate to severe right ventricular (RV) hypokinesis or dysfunction
* Left ventricular dysfunction: Defined as ejection fraction (LVEF) less than 45% on echocardiography, ventriculography, computed tomography (CT), or magnetic resonance imaging (MRI)
* Patients requiring concomitant cardiac surgery: For example, significant coronary artery disease (CAD) requiring surgical grafting

Where this trial is running

Edmonton, Alberta and 3 other locations

• Univeristy of Alberta &amp; Alberta Health Services — Edmonton, Alberta, Canada (Not_yet_recruiting)
• Vancouver General Hospital — Vancouver, British Columbia, Canada (Not_yet_recruiting)
• University Health Network / Toronto General Hospiatl — Toronto, Ontario, Canada (Not_yet_recruiting)
• Centre Hospitalier de l'Universite de Montreal — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Basil Nasir, MD

Conditions Respiratory Failure; Interstitial Lung Disease; Pulmonary Fibrosis; COPD; ECMO; Lung Transplantation