Respiratory FailureREVOLUTIONNCT06615492
Routine vs On-demand ECMO for Lung Transplantation
A study testing Routine ECMO and On-demand ECMO in people with Respiratory Failure and Interstitial Lung Disease (ILD), run by Centre hospitalier de l'Université de Montréal (CHUM) at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Interstitial Lung Disease (ILD), Pulmonary Fibrosis
- What is being tested?
- Routine ECMO and On-demand ECMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 4 sitesCanada
- Study dates
- 5 Nov 2024to 15 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lung transplant surgery
Who cannot join
- 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):
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Not yet recruiting
Univeristy of Alberta & Alberta Health Services
Edmonton, Alberta, T6G2G3
Jason Weatherald, MD, MSc, 780 492 9937, weathera@ualberta.ca
Jayan Nagendran, MD PhD
- Recruiting
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X3E4
Basil Nasir, MD, 514-890-8000 ext. 24543, basilsnasir@gmail.com
Alex Moore, MD, 514-890-8000 ext. 12171, alex.moore@umontreal.ca
- Not yet recruiting
University Health Network / Toronto General Hospiatl
Toronto, Ontario, M5G 1M1
Marcelo Cypel, MD, MSc, 4163404800, marcelo.cypel@uhn.ca
Laura Donahoe, MD, MSc
- Not yet recruiting
Vancouver General Hospital
Vancouver, British Columbia
Christopher Durkin, MD, 604 875-4111, Christopher.durkin@vch.ca
About this study
Official title: RoutinE Versus On-demand Intraoperative Extracorporeal Membrane Oxygenation (ECMO) During LUng TransplantatION (REVOLUTION)
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.
Read the 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)
- Being tested
- Routine ECMO, On-demand ECMO
- Keywords
- ECMO, Lung Transplantation
- Medical subject headings
- Respiratory Insufficiency, Lung Diseases, Interstitial, Pulmonary Fibrosis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine ECMODevice
Routine intraoperative venoarterial ECMO during lung transplant
On-demand ECMODevice
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
| Study group | Role | What they receive |
|---|---|---|
| Routine ECMO | Experimental | Routine ECMO during lung tansplant Receives: Device: Routine ECMO |
| On-demand ECMO | Active comparator | Selective, indication-based intraoperative cardiopulmonary support. Receives: Device: On-demand ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU-free days
Intensive care unit (ICU)-free days in the first 28 days post-lung transplant (28 minus the ICU length of stay)
Measured: 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
The definition is based on the criteria for the International Society of Heart and Lung Transplantation (ISHLT) grading system.
Measured: From the end of surgery up to 72 hours after surgery
Incidence of all-cause mortality
Death, whatever the cause
Measured: From the end of surgery to 90 days after surgery
Incidence of intraoperative blood product transfusion requirements
Number of packed red blood cell units and total blood product units (red blood cells, plasma, platelets, prothrombin complex concentrates) transfused.
Measured: Beginning from the surgical incision up to the arrival to the intensive care unit immediately after surgery
Incidence of perioperative blood product transfusion
Number of packed red blood cell units and total blood product units (red blood cells, plasma, platelets, prothrombin complex concentrates) transfused.
Measured: From the beginning of surgery up to 72 hours after surgery.
Intensive care unit and hospital length of stay in days
Lenght of stay in the intensive care and in the hospital
Measured: Beginning from the arrival to the intensive care unit immediately after surgery
Incidence of re-intubation after surgery
Need to reintubate after extubation after surgery
Measured: From the end of surgery until 28 days after surgery
Acute kidney injury (AKI)
The definition of AKI is based on Kidney Disease; improving global outcomes (KDIGO) classification
Measured: From the end of surgery up to 28 days after surgery
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
Composite outcome of potential complications related to routine and on-demand ECMO
Measured: From the end of surgery up to 3, 14, 28 and 90 days.
Average financial costs and sustainability metrics
The average dollar costs and waste in kg per patient related to the use of ECMO, including perfusionist labour and all materials.
Measured: From the beginning of surgery until 28 days after surgery
Incidence of postoperative stroke / cerebrovascular accident
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
Measured: From the end of surgery up to 28 days after surgery
Incidence of postoperative bleeding complications
The definition of bleeding complication is based on Bleeding Academic Research Consortium (BARC) classification. Bleeding is defined as Major or Minor.
Measured: From the end of surgery up to 28 days after surgery
Duration of mechanical ventilation in hours
BiPAP and CPAP are not considered mechanical ventilation. Tracheostomy is not considered mechanical ventilation if a ventilator is not needed.
Measured: Beginning from the arrival to the intensive care unit immediately after surgery
Incidence of postoperative tracheostomy
Need for a tracheostomy after surgery in a patient without a previous tracheostomy
Measured: From the end of surgery until 28 days after surgery
Incidence of vascular complications
Major or minor vascular complications (see protocol)
Measured: From the end of surgery to 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start5 Nov 2024
- Primary completion5 Nov 2028 (estimated)
- Study completion15 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615492
- Sponsor's protocol ID
- 2024-11391
- Acronym
- REVOLUTION
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38423414
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RoutinE Versus On-demand Intraoperative Extracorporeal Membrane Oxygenation (ECMO) During LUng TransplantatION (REVOLUTION)
- ClinicalTrials.gov ID
- NCT06615492
- Acronym / sponsor ID
- REVOLUTION / 2024-11391
- Conditions
- Respiratory Failure, Interstitial Lung Disease (ILD), Pulmonary Fibrosis, COPD (Chronic Obstructive Pulmonary Disease)
- Keywords
- ECMO, Lung Transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 5 Nov 2028 (estimated)
- Study completion
- 15 Jan 2029 (estimated)
- First posted
- 26 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine ECMO | Experimental | Device: Routine ECMORoutine ECMO during lung tansplant |
| On-demand ECMO | Active comparator | Device: On-demand ECMOSelective, indication-based intraoperative cardiopulmonary support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing lung transplant surgery
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine ECMORoutine intraoperative venoarterial ECMO during lung transplant | Device | Routine ECMO |
| On-demand ECMOSelective, 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 | Device | On-demand ECMO |
Primary outcome
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)
14 secondary outcomes
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
Incidence of all-cause mortality
Time frame: From the end of surgery to 90 days after surgery
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
Incidence of perioperative blood product transfusion
Time frame: From the beginning of surgery up to 72 hours after surgery.
Intensive care unit and hospital length of stay in days
Time frame: Beginning from the arrival to the intensive care unit immediately after surgery
Incidence of re-intubation after surgery
Time frame: From the end of surgery until 28 days after surgery
Acute kidney injury (AKI)
Time frame: From the end of surgery up to 28 days after surgery
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.
Average financial costs and sustainability metrics
Time frame: From the beginning of surgery until 28 days after surgery
Incidence of postoperative stroke / cerebrovascular accident
Time frame: From the end of surgery up to 28 days after surgery
Incidence of postoperative bleeding complications
Time frame: From the end of surgery up to 28 days after surgery
Duration of mechanical ventilation in hours
Time frame: Beginning from the arrival to the intensive care unit immediately after surgery
Incidence of postoperative tracheostomy
Time frame: From the end of surgery until 28 days after surgery
Incidence of vascular complications
Time frame: From the end of surgery to 28 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 38423414Nasir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine ECMO and On-demand ECMO in people with Respiratory Failure and Interstitial Lung Disease (ILD), run by Centre hospitalier de l'Université de Montréal (CHUM) at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Basil Nasir, MD (514-890-8000 ext. 24543, basilsnasir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU-free days (time frame: From the end of surgery up to 28 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06615492, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.