Lung Transplant Clinical Trial
Official title:
Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial
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.
Status | Recruiting |
Enrollment | 228 |
Est. completion date | September 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Hannover Medical School | Hannover | |
United States | Baylor College of Medicine | Houston | Texas |
United States | University Of Louisville | Louisville | Kentucky |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Lung Graft Dysfunction (PGD) grade 3 | Rate of PGD according to the The International Society for Heart and Lung Transplantation (ISHLT) classification | 48-72 hours | |
Primary | Mortality | Death rate of subjects following lung transplantation | 90 days | |
Primary | Primary Lung Graft Dysfunction (PGD) grade 3 and Mortality | 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 | 48-72 hours and 90 days | |
Secondary | Red blood cell transfusions | Number of subjects to require red blood cell transfusions | Intraoperative plus the first 24 hours in the ICU | |
Secondary | Chest tube output | Chest tube output the first 24 hours following lung transplantation reported in cubic centimeter (cc) | First 24 hours | |
Secondary | Incidence of re-exploration for bleeding | Number of subject to require re-exploration for bleeding | First 48 hours | |
Secondary | Incidence of air emboli | Number of subjects to experience air emboli | During VA ECMO run | |
Secondary | Incidence of stroke | Number of subjects to experience stroke | 90 days or discharge from the index hospitalization | |
Secondary | Incidence of Primary Lung Graft Dysfunction (PGD) grade 3 | 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 | At 0 hours (ICU arrival) and 24 hours | |
Secondary | Incidence of pneumonia | Number of subjects to experience pneumonia | 90 days or discharge from the index hospitalization | |
Secondary | Incidence of need for dialysis | Number of subjects to need dialysis | 90 days or discharge from the index hospitalization | |
Secondary | Incidence of transplant rejection | Number of subjects to experience transplant rejection | 90 days or discharge from the index hospitalization | |
Secondary | Incidence of bronchial dehiscence | Number of subjects to experience bronchial dehiscence | 90 days or discharge from the index hospitalization | |
Secondary | Incidence of tracheostomy | Number of subjects to require tracheostomy | 90 days or discharge from the index hospitalization | |
Secondary | Length of mechanical ventilation | Total amount of time subjects require mechanical ventilation following lung transplantation | 90 days or discharge from the index hospitalization | |
Secondary | Length of stay | Total amount of time subjects are hospitalized | 90 days or discharge from the index hospitalization |
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