Clinical trial NCT03021538: Bypass vs. Ecmo in Lung Transplantation (BELT)
Official title: Randomized Clinical Trial of Intraoperative Extracorporeal Membrane Oxygenation (ECMO) Versus Cardiopulmonary Bypass (CPB) in Lung Transplantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Transplant; Complications
Keywords: Cardiopulmonary Bypass
Extracorporeal Membrane Oxygenation
Primary Graft Dysfunction
Hemorrhage
Mechanical Ventilator
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Need for Blood Transfusion
timeFrame: 72 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Michael Tong, M.D., M.B.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoechter DJ, von Dossow V, Winter H, Muller 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.
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.
citation: 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.
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.