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

Not Applicable

Recruiting

• Conditions: Lung Transplant
• Interventions: Procedure: Off-pump lung transplantation; Procedure: Venoarterial ECMO lung transplantation

• Registration Number: NCT05547698
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-09-15
• Study Start: 2022-09-17
• Study First Submitted QC: 2022-09-19
• Study First Posted: 2022-09-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-03
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Off-Pump Bilateral Lung Transplantation	Off-pump lung transplantation	Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care
Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation	Venoarterial ECMO lung transplantation	Subjects will receive VA ECMO technique for lung transplantation as part of standard of care

Primary Outcome Measures

Name	Time	Method
Mortality	90 days	Death rate of subjects following lung transplantation
Primary Lung Graft Dysfunction (PGD) grade 3	48-72 hours	Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification
Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality	48-72 hours and 90 days	Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification plus the Death rate of subjects following lung transplantation

Secondary Outcome Measures

Name	Time	Method
Length of stay	90 days or discharge from the index hospitalization	Total amount of time subjects are hospitalized
Incidence of air emboli	During VA ECMO run	Number of subjects to experience air emboli
Incidence of stroke	90 days or discharge from the index hospitalization	Number of subjects to experience stroke
Incidence of tracheostomy	90 days or discharge from the index hospitalization	Number of subjects to require tracheostomy
Chest tube output	First 24 hours	Chest tube output the first 24 hours following lung transplantation reported in cubic centimeter (cc)
Incidence of Primary Lung Graft Dysfunction (PGD) grade 3	At 0 hours (ICU arrival) and 24 hours	Number of subjects to experience a PGD grade 3 following lung transplantation. PGD will be rated according to the The International Society for Heart and Lung Transplantation (ISHLT) classification
Incidence of pneumonia	90 days or discharge from the index hospitalization	Number of subjects to experience pneumonia
Incidence of re-exploration for bleeding	First 48 hours	Number of subject to require re-exploration for bleeding
Incidence of need for dialysis	90 days or discharge from the index hospitalization	Number of subjects to need dialysis
Incidence of bronchial dehiscence	90 days or discharge from the index hospitalization	Number of subjects to experience bronchial dehiscence
Red blood cell transfusions	Intraoperative plus the first 24 hours in the ICU	Number of subjects to require red blood cell transfusions
Incidence of transplant rejection	90 days or discharge from the index hospitalization	Number of subjects to experience transplant rejection
Length of mechanical ventilation	90 days or discharge from the index hospitalization	Total amount of time subjects require mechanical ventilation following lung transplantation

Trial Locations

Locations (7)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Hannover Medical School; 🇩🇪 Hannover, Germany

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

University Of Louisville; 🇺🇸 Louisville, Kentucky, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States