Clinical trial NCT05547698: A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation
Official title: Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplant
Keywords: Bilateral
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Lung Graft Dysfunction (PGD) grade 3
timeFrame: 48-72 hours
measure: Mortality
timeFrame: 90 days
measure: Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality
timeFrame: 48-72 hours and 90 days
Secondary outcomes:
measure: Red blood cell transfusions
timeFrame: Intraoperative plus the first 24 hours in the ICU
measure: Chest tube output
timeFrame: First 24 hours
measure: Incidence of re-exploration for bleeding
timeFrame: First 48 hours
measure: Incidence of air emboli
timeFrame: During VA ECMO run
measure: Incidence of stroke
timeFrame: 90 days or discharge from the index hospitalization
measure: Incidence of Primary Lung Graft Dysfunction (PGD) grade 3
timeFrame: At 0 hours (ICU arrival) and 24 hours
measure: Incidence of pneumonia
timeFrame: 90 days or discharge from the index hospitalization
measure: Incidence of need for dialysis
timeFrame: 90 days or discharge from the index hospitalization
measure: Incidence of transplant rejection
timeFrame: 90 days or discharge from the index hospitalization
measure: Incidence of bronchial dehiscence
timeFrame: 90 days or discharge from the index hospitalization
measure: Incidence of tracheostomy
timeFrame: 90 days or discharge from the index hospitalization
measure: Length of mechanical ventilation
timeFrame: 90 days or discharge from the index hospitalization
measure: Length of stay
timeFrame: 90 days or discharge from the index hospitalization
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Mayo Clinic
name: Mauricio Villavicencio, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: