No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
218 (estimated)
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) · Other
Who this trial is looking for
This trial is looking for patients who need a lung transplant. If you join, you will help study different methods of support during the surgery.
Are You a Good Fit for This Trial?
You may be able to join if
I am undergoing lung transplant surgery
You may not be able to join if
I cannot provide consent for the study
I have had a lung transplant before
I am having multiple organs transplanted at once
I cannot take standard heparin anticoagulation
I have severe pulmonary hypertension
I have moderate to severe right ventricular dysfunction
I have left ventricular dysfunction with an ejection fraction less than 45%
I need heart surgery at the same time
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Status
Eligibility Criteria
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 r…
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):
1. Systolic pulmonary artery pressure (PAP) ≥ 80 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
2. Mean PAP ≥ 55 mm Hg on the most recent echocardiography, right heart catheterization, or pulmonary artery catheter measurement
3. 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
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