Recruiting

CPB vs. ECMO

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06615492

Conditions

Respiratory Failure

Interstitial Lung Disease (ILD)

Pulmonary Fibrosis

COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Routine ECMO

On-demand ECMO

Study Details

Brief summary:

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.

Conditions

Respiratory Failure

Interstitial Lung Disease (ILD)

Pulmonary Fibrosis

COPD (Chronic Obstructive Pulmonary Disease)

Study ID

NCT06615492

Start date

Nov 5, 2024

Status verified date

Dec, 2025

Completion date

Jan 15, 2029

Anticipated

Primary completion date

Nov 5, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

218 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Routine ECMO

Routine ECMO during lung tansplant

active comparator: On-demand ECMO

Selective, indication-based intraoperative cardiopulmonary support.

Interventions

Routine ECMO

Routine intraoperative venoarterial ECMO during lung transplant

On-demand ECMO

Selective, indication-based intraoperative cardiopulmonary support. In this group, the transplant will be planned without cardiopulmonary support. intraoperative venoarterial ECMO will be used selectively based on hemodynamic and/or gas exchange abnormalities :

1. Inability to maintain adequate hemodynamics and stable perfusion despite volume resuscitation and vasopressor administration and in the absence of readily correctable cause
2. Inability to tolerate pulmonary artery clamping
3. Inadequate gas exchange despite attempts at the optimization of ventilator parameters and treatments related to respiratory mechanics and ventilation/perfusion matching
4. Inadequate exposure to the surgical field
5. The transplant team is concerned about the ability to maintain organ perfusion or ventilate with a lung protective strategy, even if the aforementioned criteria are unmet.
6. Concerns about donor lung quality and a desire to protect the implanted lung from single lung perfusion

Primary outcome measure

  • ICU-free days [ Time Frame: From the end of surgery up to 28 days after surgery ]

Central Contacts and Locations

Locations

Centre Hospitalier de l'Universite de Montreal

Recruiting

Montreal, Quebec, Canada, H2X3E4

Contacts

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

  • ECMO
  • Lung Transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-12-23.