Routine vs On-demand ECMO for Lung Transplantation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About 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 does not accept healthy volunteers

Qualifiers

Patients undergoing lung transplant surgery

Disqualifiers

Inability to provide consent for the study

Retransplantation

Multi-organ transplantation

Contra-indication to standard heparin anticoagulation (e.g., heparin-induced thrombocytopenia)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Routine ECMO

    Device

    Routine intraoperative venoarterial ECMO during lung transplant

  • On-demand ECMO

    Device

    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 : 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

Treatment groups

218 Participants
are divided into 2 treatment groups
Group A: Routine ECMOExperimental treatment 1 intervention
Group B: On-demand ECMOActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ICU-free days

Intensive care unit (ICU)-free days in the first 28 days post-lung transplant (28 minus the ICU length of stay)

Time frame
From the end of surgery up to 28 days after surgery

Secondary outcomes

1

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.

Time frame
From the end of surgery up to 72 hours after surgery
2

Incidence of all-cause mortality

Death, whatever the cause

Time frame
From the end of surgery to 90 days after surgery
3

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.

Time frame
Beginning from the surgical incision up to the arrival to the intensive care unit immediately after surgery
4

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.

Time frame
From the beginning of surgery up to 72 hours after surgery.

Other outcomes

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