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NCT03021538 Clinical Trial

Bypass vs. Ecmo in Lung Transplantation (BELT)

Lung Transplant; Complications Clinical Trial

— BELT  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03021538
Other study ID # 17-166
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 17, 2017
Est. completion date January 24, 2019

Study information
Verified date March 2020
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 13
Est. completion date January 24, 2019
Est. primary completion date January 24, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Extracorporeal Membrane Oxygenation
ECMO is used during lung transplant procedure
• Cardiopulmonary Bypass
CPB is used during lung transplant procedure

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (4)

Bermudez CA, Shiose A, Esper SA, Shigemura N, D'Cunha J, Bhama JK, Richards TJ, Arlia P, Crespo MM, Pilewski JM. Outcomes of intraoperative venoarterial extracorporeal membrane oxygenation versus cardiopulmonary bypass during lung transplantation. Ann Thorac Surg. 2014 Dec;98(6):1936-42; discussion 1942-3. doi: 10.1016/j.athoracsur.2014.06.072. Epub 2014 Oct 22. — View Citation

Hoechter DJ, von Dossow V, Winter H, Müller HH, Meiser B, Neurohr C, Behr J, Guenther S, Hagl C, Schramm R. The Munich Lung Transplant Group: Intraoperative Extracorporeal Circulation in Lung Transplantation. Thorac Cardiovasc Surg. 2015 Dec;63(8):706-14. doi: 10.1055/s-0035-1556873. Epub 2015 Aug 20. — View Citation

Ius F, Kuehn C, Tudorache I, Sommer W, Avsar M, Boethig D, Fuehner T, Gottlieb J, Hoeper M, Haverich A, Warnecke G. Lung transplantation on cardiopulmonary support: venoarterial extracorporeal membrane oxygenation outperformed cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1510-6. doi: 10.1016/j.jtcvs.2012.07.095. Epub 2012 Aug 31. — View Citation

Machuca TN, Collaud S, Mercier O, Cheung M, Cunningham V, Kim SJ, Azad S, Singer L, Yasufuku K, de Perrot M, Pierre A, McRae K, Waddell TK, Keshavjee S, Cypel M. Outcomes of intraoperative extracorporeal membrane oxygenation versus cardiopulmonary bypass for lung transplantation. J Thorac Cardiovasc Surg. 2015 Apr;149(4):1152-7. doi: 10.1016/j.jtcvs.2014.11.039. Epub 2014 Nov 21. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Need for Blood Transfusion Number of pRBC transfusion that resulted due to postoperative bleeding 72 hours after surgery
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