NCT06615492 Routine vs On-demand ECMO for Lung Transplantation

Eligibility & Interventions

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This trial targets 218 participants in total. It began in 2024-11-05 with a primary completion date of 2028-11-05.

Brief 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. 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

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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