ECMO Methods for Lung Disease

(REVOLUTION Trial)

Not yet recruiting at 4 trial locations

Overseen By Alex Moore, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Heparin

Disqualifiers: Retransplantation, Multi-organ transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether using a special machine called ECMO during lung transplants is more effective when used continuously or only as needed. ECMO supports the heart and lungs by pumping blood through a machine to add oxygen and remove carbon dioxide. The trial compares routine ECMO use with its use only when a patient shows signs of needing extra heart and lung support. Eligible participants include those undergoing lung transplant surgery who do not have severe heart issues or require multiple organ transplants. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance lung transplant procedures.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a contraindication to standard heparin anticoagulation, you may not be eligible to participate.

What prior data suggests that these ECMO methods are safe for lung transplantation?

Research has shown that ECMO, a type of life support, links to fewer complications than the traditional method used during lung transplants. One study found that ECMO reduces post-surgery problems, leading to smoother recovery. As a result, many centers now prefer ECMO for lung transplant surgeries.

Although ECMO is generally well-tolerated, some risks of bleeding and infection remain, though these occur less frequently than with the traditional method. This suggests ECMO could be a safer option for patients undergoing lung transplants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring ECMO (Extracorporeal Membrane Oxygenation) methods for lung disease because these methods might offer more personalized and adaptable support during lung transplants. Unlike the standard approach of routine ECMO, which provides constant cardiopulmonary support throughout the procedure, the on-demand ECMO approach is tailored to specific patient needs, offering support only when necessary. This selective use not only has the potential to reduce unnecessary exposure to ECMO but could also minimize associated risks and improve patient outcomes. By comparing these two approaches, researchers hope to determine if a more flexible ECMO strategy leads to better recovery and fewer complications for lung transplant patients.

What evidence suggests that ECMO methods are effective for lung disease?

This trial will compare two ECMO methods for lung transplants: Routine ECMO and On-demand ECMO. Studies have shown that ECMO can be a helpful tool during lung transplants. Research indicates that ECMO use is linked to fewer complications after surgery compared to the traditional heart-lung machine. This suggests that patients might recover more smoothly with reduced risks of problems like bleeding. ECMO also has a strong record of helping very sick patients through surgery. Overall, ECMO is considered a beneficial support method during these complex procedures. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients with severe lung diseases like COPD or pulmonary fibrosis who are undergoing lung transplantation. It's not specified who can't join, but typically those with conditions that could complicate surgery or recovery might be excluded.

Inclusion Criteria

I am scheduled for a lung transplant surgery.

Exclusion Criteria

I cannot use standard blood thinners due to a bad reaction.

My heart's right side is weak or not pumping well.

I need heart surgery in addition to my current treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Lung transplantation surgery with either routine or on-demand ECMO support

1 day

1 visit (in-person)

Postoperative Care

Participants are monitored in the ICU and hospital for recovery and complications

28 days

Daily monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

What Are the Treatments Tested in This Trial?

Interventions

• On-demand ECMO
• Routine ECMO

Trial Overview The study compares two ways of using ECMO, a machine that helps breathe and circulate blood during lung transplant surgery: one group gets ECMO routinely, while the other only when it's necessary due to complications.

How Is the Trial Designed?

Group I: Routine ECMO Experimental Treatment 1 Intervention

Routine ECMO during lung tansplant

Group II: On-demand ECMO Active Control 1 Intervention

Selective, indication-based intraoperative cardiopulmonary support.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11661783/

Enhancing lung transplantation with ECMO - PubMed Central The study highlighted a successful ECMO weaning rate and indicated that ECMO was an effective adjunctive support during surgery for critically ill lung ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1015958425005603

The efficacy and safety of ECMO and CPB in lung ... In comparison to traditional intraoperative cardiopulmonary bypass (CPB), ECMO offers several advantages, including a reduction in postoperative complications.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06615492

Routine vs On-demand ECMO for Lung Transplantation This study compares two approaches to intraoperative cardiopulmonary support during lung transplantation: routine cardiopulmonary support with extracorporeal ...

4. link.springer.com link.springer.com/article/10.1007/s13665-025-00379-y

Bridge to Lung Transplantation Utilizing Extracorporeal ... Modern studies of ECMO as a BTT incorporating data from the 2000 s onward highlight its effectiveness in patients with severe or rapidly ...

5. atsjournals.org atsjournals.org/doi/10.1164/rccm.201602-0312ED

Lung Transplant and Extracorporeal Membrane ... Recent reports have suggested a volume–outcome relationship in both ECMO and lung transplantation (7, 8), and understanding the interplay between center volume ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5757030/

Outcomes of perioperative extracorporeal membrane ... After a median of 17.7 months (range, 3.1–40.9 months) for survivors, the one year overall survival (OS) rates after LTx for the three groups were 76.3%±5.2% ...

7. jhltonline.org jhltonline.org/article/S1053-2498(24)01496-7/fulltext

Randomized trial of routine versus on-demand ... In this publication, we describe a feasibility study to assess the practicality of a protocol comparing routine versus selective VA-ECMO during ...

8. mdpi.com mdpi.com/2077-0383/14/12/4195

Six-Year Single-Center Experience with ECMO Use in ... Early (60-day) and long-term (two-year) survival analysis of patients with iPAH undergoing lung transplantation with ECMO did not show statistically significant ...