ECMO Methods for Lung Disease
(REVOLUTION Trial)
Trial Summary
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 data supports the effectiveness of the treatment On-demand ECMO, Routine ECMO for lung disease?
Research shows that ECMO (extracorporeal membrane oxygenation) can be a safe and effective treatment for severe lung problems like acute respiratory distress syndrome (ARDS). It helps protect patients from low oxygen levels and allows time for the lungs to heal, especially if the lung damage is reversible.12345
Is ECMO generally safe for humans?
ECMO (extracorporeal membrane oxygenation) is a life support treatment that can be lifesaving for people with severe heart and lung problems, but it does come with risks. Common complications include bleeding, blood clots, and equipment failures. However, in some studies, ECMO has been shown to be a safe option, especially in specific cases like lung transplants, where it has a high survival rate.678910
How does the treatment Routine ECMO differ from other treatments for lung disease?
Routine ECMO (extracorporeal membrane oxygenation) is unique because it provides external support for gas exchange, allowing the lungs to rest and heal, which is particularly useful in severe lung conditions or as a bridge to lung transplantation. Unlike other treatments, ECMO can be tailored to individual needs with various configurations and is often used when conventional therapies are insufficient.1011121314
What is the purpose of this trial?
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.
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Lung transplantation surgery with either routine or on-demand ECMO support
Postoperative Care
Participants are monitored in the ICU and hospital for recovery and complications
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- On-demand ECMO
- Routine ECMO
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor