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Recruiting NCT05547698

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

No phase Interventional Lung Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Off-pump lung transplantation, Venoarterial ECMO lung transplantation.
Who it may be relevant to
Registry conditions: Lung Transplant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial

Overview

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.

Interventions

  • Procedure Off-pump lung transplantation
    General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, pneumonectomy starting by the less perfused lung in the scan, stump preparation, lung implantation, reperfusion, gradual release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, chest closure.
  • Procedure Venoarterial ECMO lung transplantation
    General anesthesia, intubation with double lumen tube, thoracotomies or clamshell incision, heparin, peripheral or central venoarterial ECMO cannulation, first pneumonectomy, stump preparation, lung implantation, reperfusion, release of the pulmonary artery clamp, deairing, ventilation of the 1st implanted lung. The process is repeated at the contralateral side. Ventilation of both lungs, ECMO decannulation, chest closure.

Primary outcome measures

  • Primary Lung Graft Dysfunction (PGD) grade 3 [Time frame: 48-72 hours]
  • Mortality [Time frame: 90 days]
  • Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality [Time frame: 48-72 hours and 90 days]
Secondary outcome measures (12)
  • Red blood cell transfusions [Time frame: Intraoperative plus the first 24 hours in the ICU]
  • Chest tube output [Time frame: First 24 hours]
  • Incidence of re-exploration for bleeding [Time frame: First 48 hours]
  • Incidence of air emboli [Time frame: During VA ECMO run]
  • Incidence of stroke [Time frame: 90 days or discharge from the index hospitalization]
  • Incidence of Primary Lung Graft Dysfunction (PGD) grade 3 [Time frame: At 0 hours (ICU arrival) and 24 hours]
  • Incidence of pneumonia [Time frame: 90 days or discharge from the index hospitalization]
  • Incidence of need for dialysis [Time frame: 90 days or discharge from the index hospitalization]
  • Incidence of transplant rejection [Time frame: 90 days or discharge from the index hospitalization]
  • Incidence of bronchial dehiscence [Time frame: 90 days or discharge from the index hospitalization]
  • Incidence of tracheostomy [Time frame: 90 days or discharge from the index hospitalization]
  • Length of mechanical ventilation [Time frame: 90 days or discharge from the index hospitalization]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 3 centers
  • University Of Louisville — Louisville
  • Mayo Clinic Rochester — Rochester
  • Baylor College of Medicine — Houston

Identifiers

NCT: NCT05547698 · 22-005691

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗