Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial: A Multicenter Prospective Randomized Trial
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Kentucky
University Of Louisville
RECRUITING
Louisville
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Pennsylvania
Temple University Hospital
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Mauricio Villavicencio, MD, MBA
villavicencio.mauricio@mayo.edu
507-2557068
Backup
Jackie Reiter
reiter.jacqulyn@mayo.edu
507-538-2224
Time Frame
Start Date: 2022-09-17
Estimated Completion Date: 2027-09
Participants
Target number of participants: 228
Treatments
Active_comparator: Off-Pump Bilateral Lung Transplantation
Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care
Active_comparator: Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation
Subjects will receive VA ECMO technique for lung transplantation as part of standard of care
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic