Routine vs On-demand ECMO for Lung Transplantation

NCT ID: NCT06615492

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-05
• Study Completion Date: 2029-01-15

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.

Detailed Description

This study compares two approaches to intraoperative cardiopulmonary support during lung transplantation: routine cardiopulmonary support with extracorporeal membrane oxygenation (ECMO) versus selective use. Despite recent improvements in lung transplant outcomes, postoperative complications are common. Intraoperative hemodynamic management is vital to the success of lung transplantation. Many centers, including all four Canadian centers, use ECMO to provide intraoperative support. However, lung transplantation without cardiopulmonary support may be possible in certain patients. In such patients, the transplant may be started without ECMO. ECMO may be initiated "on-demand" if hemodynamic embarrassment or hypoxia occurs. Conversely, the opposite approach would be routinely conducting all lung transplants using ECMO. The current practice in many centers is to use ECMO selectively. By extension, the investigators believe that more liberal use of intraoperative ECMO will produce less intraoperative hemodynamic instability and hypoxia. However, it is unclear the extent of ECMO use necessary to improve the incidence of postoperative hypoperfusion-related complications. Should ECMO be used routinely in all patients or selectively based on the intraoperative course? The study is a prospective, randomized, controlled trial with two treatment arms: routine support with ECMO versus selective (on-demand) support with ECMO. Study population (Inclusion and exclusion criteria): All patients, 18 years of age or older, undergoing lung transplantation will be screened for participation. We will exclude patients who require intraoperative ECMO, multi-organ transplants, and retransplantation Arms and Interventions: On-demand ECMO: The transplant will be planned without cardiopulmonary support in this group. Intraoperative ECMO will be employed if there is an inability to maintain adequate organ perfusion and oxygen delivery despite resuscitation. Routine ECMO: Routine intraoperative ECMO in all patients, regardless of hemodynamic status. Primary outcome: Intensive care unit (ICU)-free days in the first 28 days post-lung transplant.

Conditions

Respiratory Failure; Interstitial Lung Disease (ILD); Pulmonary Fibrosis; COPD (Chronic Obstructive Pulmonary Disease)

Keywords

ECMO; Lung Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Routine ECMO

Routine ECMO during lung tansplant

Group Type: EXPERIMENTAL

Routine ECMO

Intervention Type: DEVICE

Routine intraoperative venoarterial ECMO during lung transplant

On-demand ECMO

Selective, indication-based intraoperative cardiopulmonary support.

Group Type: ACTIVE_COMPARATOR

On-demand ECMO

Intervention Type: DEVICE

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

Interventions

Routine ECMO

Routine intraoperative venoarterial ECMO during lung transplant

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Univeristy of Alberta & Alberta Health Services

Edmonton, Alberta, Canada

Site Status: NOT_YET_RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status: NOT_YET_RECRUITING

University Health Network / Toronto General Hospiatl

Toronto, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Basil Nasir, MD

Role: CONTACT

Phone: 514-890-8000

Email: basilsnasir@gmail.com

Alex Moore, MD

Role: CONTACT

Phone: 514-890-8000

Email: alex.moore@umontreal.ca

Facility Contacts

Jason Weatherald, MD, MSc

Role: primary

Christopher Durkin, MD

Role: primary

Marcelo Cypel, MD, MSc

Role: primary

Basil Nasir, MD

Role: primary

Alex Moore, MD

Role: backup

References

Nasir BS, Weatherald J, Ramsay T, Cypel M, Donahoe L, Durkin C, Schisler T, Nagendran J, Liberman M, Landry C, Overbeek C, Moore A, Ferraro P. Randomized trial of routine versus on-demand intraoperative extracorporeal membrane oxygenation in lung transplantation: A feasibility study. J Heart Lung Transplant. 2024 Jun;43(6):1005-1009. doi: 10.1016/j.healun.2024.02.1454. Epub 2024 Feb 28.

Reference Type: BACKGROUND

PMID: 38423414 (View on PubMed)

Other Identifiers

2024-11391

Identifier Type: -

Identifier Source: org_study_id