Routine vs On-demand ECMO for Lung Transplantation

NCT06615492 | Recruiting DMC

• 1 other identifier: 2024-11391
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 4

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)

Keywords

ECMO; Lung Transplantation

Outcome Measures

Primary Outcomes (1)

• ICU-free days

  Intensive care unit (ICU)-free days in the first 28 days post-lung transplant (28 minus the ICU length of stay)

  From the end of surgery up to 28 days after surgery

Secondary Outcomes (14)

• Incidence and grade of primary graft dysfunction (PGD) at 0, 24, 48, and 72 hours

  From the end of surgery up to 72 hours after surgery

• Incidence of all-cause mortality

  From the end of surgery to 90 days after surgery

• Incidence of intraoperative blood product transfusion requirements

  Beginning from the surgical incision up to the arrival to the intensive care unit immediately after surgery

• Incidence of perioperative blood product transfusion

  From the beginning of surgery up to 72 hours after surgery.

• Intensive care unit and hospital length of stay in days

  Beginning from the arrival to the intensive care unit immediately after surgery

Study Arms (2)

Routine ECMO

EXPERIMENTAL

Routine ECMO during lung tansplant

Device: Routine ECMO

On-demand ECMO

ACTIVE COMPARATOR

Selective, indication-based intraoperative cardiopulmonary support.

Device: On-demand ECMO

Interventions

Routine ECMO DEVICE

Routine intraoperative venoarterial ECMO during lung transplant

Routine ECMO

On-demand ECMO 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

On-demand ECMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lung transplant surgery

You may not qualify if:

• 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):
• 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
• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (4)

Univeristy of Alberta & Alberta Health Services

Edmonton, Alberta, T6G2G3, Canada

NOT YET RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, Canada

NOT YET RECRUITING

University Health Network / Toronto General Hospiatl

Toronto, Ontario, M5G 1M1, Canada

NOT YET RECRUITING

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X3E4, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 38423414 BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency; Lung Diseases, Interstitial; Pulmonary Fibrosis; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes

Central Study Contacts

Basil Nasir, MD

CONTACT

514-890-8000; basilsnasir@gmail.com

Alex Moore, MD

CONTACT

514-890-8000; alex.moore@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: November 5, 2024
• Primary Completion (Estimated): November 5, 2028
• Study Completion (Estimated): January 15, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)