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NCT Number: NCT06615492

Routine vs On-demand ECMO for Lung Transplantation

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.

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Key information

Conditions

Respiratory Failure COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Fibrosis Interstitial Lung Disease (ILD) Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Alberta & Alberta Health Services, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • 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

Treatment and study plan

Routine ECMO

Device

Routine intraoperative venoarterial ECMO during lung transplant

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 :

  • Inability to maintain adequate hemodynamics and stable perfusion despite volume resuscitation and vasopressor administration and in the absence of readily correctable cause
  • Inability to tolerate pulmonary artery clamping
  • Inadequate gas exchange despite attempts at the optimization of ventilator parameters and treatments related to respiratory mechanics and ventilation/perfusion matching
  • Inadequate exposure to the surgical field
  • 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.
  • Concerns about donor lung quality and a desire to protect the implanted lung from single lung perfusion

Primary outcomes

  1. ICU-free days

    Time frame: From the end of surgery up to 28 days after surgery

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

Secondary outcomes

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

    Time frame: From the end of surgery up to 72 hours after surgery

    The definition is based on the criteria for the International Society of Heart and Lung Transplantation (ISHLT) grading system.

  2. Incidence of all-cause mortality

    Time frame: From the end of surgery to 90 days after surgery

    Death, whatever the cause

  3. Incidence of intraoperative blood product transfusion requirements

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

    Number of packed red blood cell units and total blood product units (red blood cells, plasma, platelets, prothrombin complex concentrates) transfused.

  4. Incidence of perioperative blood product transfusion

    Time frame: From the beginning of surgery up to 72 hours after surgery.

    Number of packed red blood cell units and total blood product units (red blood cells, plasma, platelets, prothrombin complex concentrates) transfused.

  5. Intensive care unit and hospital length of stay in days

    Time frame: Beginning from the arrival to the intensive care unit immediately after surgery

    Lenght of stay in the intensive care and in the hospital

  6. Incidence of re-intubation after surgery

    Time frame: From the end of surgery until 28 days after surgery

    Need to reintubate after extubation after surgery

  7. Acute kidney injury (AKI)

    Time frame: From the end of surgery up to 28 days after surgery

    The definition of AKI is based on Kidney Disease; improving global outcomes (KDIGO) classification

  8. The composite incidence of death, disabling stroke, grade 2 or 3 PGD at 72 hours, major bleeding, vascular complications, or stage II or III acute kidney injury

    Time frame: From the end of surgery up to 3, 14, 28 and 90 days.

    Composite outcome of potential complications related to routine and on-demand ECMO

  9. Average financial costs and sustainability metrics

    Time frame: From the beginning of surgery until 28 days after surgery

    The average dollar costs and waste in kg per patient related to the use of ECMO, including perfusionist labour and all materials.

  10. Incidence of postoperative stroke / cerebrovascular accident

    Time frame: From the end of surgery up to 28 days after surgery

    Stroke, disabling stroke or non-disabling stroke.

    • Stroke: Duration of a focal or global neurological deficit ≥ 24 hours; OR < 24 hours if neuroimaging shows a new hemorrhage or infarct; OR the neurological deficit results in death
    • Disabling stroke: A modified Rankin Score (mRS) of ≥ 2 at three days OR an increase in at least one mRS category from baseline for individuals with a pre-stroke baseline ≥ 1 16,17.
    • Non-disabling stroke: An mRS score of < 2 at 14 days or one that does not increase in at least one mRS category from an individuals pre-stroke baseline

  11. Incidence of postoperative bleeding complications

    Time frame: From the end of surgery up to 28 days after surgery

    The definition of bleeding complication is based on Bleeding Academic Research Consortium (BARC) classification. Bleeding is defined as Major or Minor.

  12. Duration of mechanical ventilation in hours

    Time frame: Beginning from the arrival to the intensive care unit immediately after surgery

    BiPAP and CPAP are not considered mechanical ventilation. Tracheostomy is not considered mechanical ventilation if a ventilator is not needed.

  13. Incidence of postoperative tracheostomy

    Time frame: From the end of surgery until 28 days after surgery

    Need for a tracheostomy after surgery in a patient without a previous tracheostomy

  14. Incidence of vascular complications

    Time frame: From the end of surgery to 28 days after surgery

    Major or minor vascular complications (see protocol)

Study contacts

Contact information is provided by the study sponsor or research team.

Alex Moore, MD

CONTACT

[email protected]

514-890-8000 ext. 12171

Basil Nasir, MD

CONTACT

[email protected]

514-890-8000 ext. 24543

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Official study title

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

Acronym: REVOLUTION

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
Sep 26, 2024
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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