Bypass vs. Ecmo in Lung Transplantation (BELT) (BELT)

March 12, 2020 updated by: Michael Zhen-Yu Tong, MD, The Cleveland Clinic

Randomized Clinical Trial of Intraoperative Extracorporeal Membrane Oxygenation (ECMO) Versus Cardiopulmonary Bypass (CPB) in Lung Transplantation

This study seeks to compare outcomes of 2 different methods of cardiopulmonary support during lung transplant surgeries.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will compare use of extracorporeal membrane oxygenation (ECMO) and heart-lung bypass (CPB) during lung transplant procedures and their short and long term outcomes.

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.

Description

Inclusion Criteria:

1. The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.

Exclusion Criteria:

  1. Patients undergoing concomitant cardiac operations with indication for obligate use of cardiopulmonary bypass
  2. Patient with specific anatomy that require full cardiac decompression such as severe pulmonary hypertension or large heart that are shifted severely into the left chest
  3. Patients with high likelihood of significant pleural bleeding that will require returning the blood back into the cardiotomy reservoir
  4. Patients bridged to transplant with ECMO
  5. Cystic fibrosis/bronchiectasis/resistant infection patients where surgeon will need to remove both lungs prior to implantation
  6. Patients who the surgeon feels would be better served with CPB rather than ECMO- These patients will be entered into a registry and followed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiopulmonary Bypass
There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.
Device: Cardiopulmonary Bypass
CPB is used during lung transplant procedure
Extracorporeal Membrane Oxygenation
There will be 40 patients placed on ECMO during lung transplantation.
Device: Extracorporeal Membrane Oxygenation
ECMO is used during lung transplant procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for Blood Transfusion
Time Frame: 72 hours after surgery
Number of pRBC transfusion that resulted due to postoperative bleeding
72 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Michael Tong, M.D., M.B.A., The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2017

Primary Completion (Actual)

January 24, 2019

Study Completion (Actual)

January 24, 2019

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 12, 2017

First Posted (Estimate)

January 16, 2017

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17-166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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