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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Mayo Clinic
Study ID
NCT05547698
Status
Recruiting
Apply to this trial

Conditions

  • Lung Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Off-pump lung transplantation — PROCEDURE
    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.
  • Venoarterial ECMO lung transplantation — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Sep 17, 2022
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
228 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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

Primary Outcome Measure

Primary Lung Graft Dysfunction (PGD) grade 3 [ Time Frame: 48-72 hours ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University Of LouisvilleLouisvilleKentucky40202
Matthew Fox, Dr.
502-587-4384
Mayo Clinic RochesterRochesterMinnesota55905
Mauricio Villavicencio Theoduloz, MD, MBA
[email protected]
507-255-7068
Jacqulyn R Reiter
[email protected]
507-538-2224
Suraj Yalamuri, MD (SUB_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Gabriel Loor, MD
[email protected]
832-355-3000
Gabriel Loor (PRINCIPAL_INVESTIGATOR)

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University Of Louisville· Louisville, KYMayo Clinic Rochester· Rochester, MNBaylor College of Medicine· Houston, TX

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