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

Overview

About this study

The purpose of this study is to determine whether off-pump bilateral orthotopic lung transplantation (BOLT) or venoarterial extracorporeal membrane oxygenation (VA ECMO) lung transplantation results in higher PGD grade 3 at 48-72 hours, mortality at 90 days, and the combination of these two endpoints.

Secondly, to determine whether off-pump or VA ECMO lung transplantation has more red blood cell transfusion (intraoperative plus the first 24 hours in the ICU), chest tube output the first 24 hours, incidence of re-exploration for bleeding, air emboli, stroke, PGD grade 3 at T0 and T24, pneumonia, need for dialysis, rejection, bronchial dehiscence, tracheostomy, length of mechanical ventilation, hospital length of stay, and a decrease in FEV1 to less than 80% of baseline FEV1 after lung transplanation

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/29/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mauricio Villavicencio Theoduloz, M.D.

Open for enrollment

Contact information:

Jacqulyn Reiter

(507) 538-2224

Reiter.Jacqulyn@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Mauricio Villavicencio Theoduloz, M.D.

Closed for enrollment

Contact information:

Jacqulyn Reiter

(507) 538-2224

Reiter.Jacqulyn@mayo.edu

More information

Publications

Publications are currently not available