NCT05547698

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Sep 2022Sep 2027

First Submitted

Initial submission to the registry

September 15, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

September 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

September 15, 2022

Last Update Submit

April 27, 2026

Conditions

Lung Transplant

Keywords

Bilateral

Outcome Measures

Primary Outcomes (3)

  • 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

  • Mortality

    Death rate of subjects following lung transplantation

    90 days

  • 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 Outcomes (13)

  • Red blood cell transfusions

    Intraoperative plus the first 24 hours in the ICU

  • Chest tube output

    First 24 hours

  • Incidence of re-exploration for bleeding

    First 48 hours

  • Incidence of air emboli

    During VA ECMO run

  • Incidence of stroke

    90 days or discharge from the index hospitalization

  • +8 more secondary outcomes

Study Arms (2)

Off-Pump Bilateral Lung Transplantation

ACTIVE COMPARATOR

Subjects will receive 'off-pump' technique for lung transplantation as part of standard of care

Procedure: Off-pump lung transplantation

Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation

ACTIVE COMPARATOR

Subjects will receive VA ECMO technique for lung transplantation as part of standard of care

Procedure: Venoarterial ECMO lung transplantation

Interventions

Off-pump lung transplantationPROCEDURE

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.

Off-Pump Bilateral Lung Transplantation
Venoarterial ECMO lung transplantationPROCEDURE

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.

Venoarterial Extra Corporeal Membrane Oxygenation (VA ECMO) Bilateral Lung Transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Single lung transplant
  • Multiorgan transplant.
  • Donor after cardiac death (DCD).
  • Re-transplant.
  • Intention to use prophylactic post-operative ECMO.
  • Previous pleurodesis.
  • Preoperative ECMO and/or mechanical ventilation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Related Links

Study Officials

  • Mauricio Villavicencio, MD, MBA

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mauricio Villavicencio, MD, MBA

CONTACT

507-2557068villavicencio.mauricio@mayo.edu

Jackie Reiter

CONTACT

507-538-2224reiter.jacqulyn@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

September 17, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)