A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation

Mayo Clinic

Status: Enrolling

Conditions: Lung Transplant

Treatments: Procedure: Off-pump lung transplantation; Procedure: Venoarterial ECMO lung transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05547698

22-005691

Details and patient eligibility

About

The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO (VA ECMO). The goal of the trial is to determine which technique has lower rates of primary graft dysfunction.

Full description

The Investigators of the Extracorporeal Life Support Registry in Lung Transplantation (ECLS Registry) has studied the impact of the type of intraoperative extracorporeal life support on primary graft dysfunction (PGD) after lung transplantation (LTx) in an international registry. The investigators have demonstrated that severe PGD at 48-72 hours is greater when LTx is performed using cardiopulmonary bypass (CPB) (43%) when compared to veno-arterial (VA) ECMO. However, PGD after VA ECMO remained high (29%) when compared to off-pump (12%). Conversely, there are retrospective series showing that when compared to off-pump technique, VA ECMO has reduced PGD rates and improved survival. Because selection bias and unknown confounders in retrospective studies could have been the cause of these conflicting results, part of the ECLS Registry Investigators are committed to a prospective multicenter randomized trial comparing off-pump versus VA ECMO LTx.

Enrollment: 228 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bilateral Lung Transplantation (LTx) recipients.
• Mean pulmonary artery pressure < or = 35 mmHg.
• Eligible for off-pump or VA ECMO based on the judgement of the attending surgeon.

Exclusion criteria

• Single lung transplant
• Multiorgan transplant.
• Donor after cardiac death (DCD).
• Re-transplant.
• Intention to use prophylactic post-operative ECMO.
• Previous major lung surgery. Video-assisted thoracoscopic surgery (VATS) and wedge resection are not an exclusion criterion.
• Previous pleurodesis.
• Preoperative ECMO and/or mechanical ventilation.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Off-Pump Bilateral Lung Transplantation

Active Comparator group

Description:

Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care

Treatment:

Procedure: Off-pump lung transplantation

Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation

Active Comparator group

Description:

Subjects will receive VA ECMO technique for lung transplantation as part of standard of care

Treatment:

Procedure: Venoarterial ECMO lung transplantation