Bypass vs. Ecmo in Lung Transplantation (BELT)

Terminated

• Conditions: Lung Transplant; Complications
• Interventions: Device: Cardiopulmonary Bypass; Device: Extracorporeal Membrane Oxygenation

• Registration Number: NCT03021538
• Lead Sponsor: The Cleveland Clinic

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-16
• Study Start: 2017-04-17
• Primary Completion: 2019-01-24
• Study Completion: 2019-01-24
• Results First Submitted: 2020-02-24
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Results First Posted: 2020-03-24
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiopulmonary Bypass	Cardiopulmonary Bypass	There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.
Extracorporeal Membrane Oxygenation	Extracorporeal Membrane Oxygenation	There will be 40 patients placed on ECMO during lung transplantation.

Primary Outcome Measures

Name	Time	Method
Need for Blood Transfusion	72 hours after surgery	Number of pRBC transfusion that resulted due to postoperative bleeding

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States