Bypass vs. Ecmo in Lung Transplantation (BELT)

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03021538
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Actual Duration (Months): 21.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Transplant; Complications	Device: Extracorporeal Membrane Oxygenation; Device: Cardiopulmonary Bypass

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 Design

• Study Type: Observational
• Actual Enrollment: 13 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Randomized Clinical Trial of Intraoperative Extracorporeal Membrane Oxygenation (ECMO) Versus Cardiopulmonary Bypass (CPB) in Lung Transplantation
• Actual Study Start Date: Apr 17, 2017
• Actual Primary Completion Date: Jan 24, 2019
• Actual Study Completion Date: Jan 24, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Need for Blood Transfusion [72 hours after surgery]

   Number of pRBC transfusion that resulted due to postoperative bleeding

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 27, 2017

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Michael Zhen-Yu Tong, MD, Cardiac Surgeon, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03021538
• Other Study ID Numbers: 17-166
• First Posted: Jan 16, 2017
• Last Update Posted: Mar 24, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Michael Zhen-Yu Tong, MD, Cardiac Surgeon, The Cleveland Clinic: Cardiopulmonary Bypass; Extracorporeal Membrane Oxygenation; Primary Graft Dysfunction; Hemorrhage; Mechanical Ventilator

Study Results

Participant Flow

Arm/Group Title	Cardiopulmonary Bypass	Extracorporeal Membrane Oxygenation
Arm/Group Description	There will be 40 patients placed on cardiopulmonary bypass during lung transplantation. Cardiopulmonary Bypass: CPB is used during lung transplant procedure	There will be 40 patients placed on ECMO during lung transplantation. Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure
Period Title: Overall Study
STARTED	6	7
COMPLETED	6	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Cardiopulmonary Bypass	Extracorporeal Membrane Oxygenation	Total
Arm/Group Description	There will be 40 patients randomized to cardiopulmonary bypass during lung transplantation. Cardiopulmonary Bypass: CPB is used during lung transplant procedure	There will be 40 patients randomized to ECMO during lung transplantation. Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure	Total of all reporting groups
Overall Participants	6	7	13
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 50%	6 85.7%	9 69.2%
>=65 years	3 50%	1 14.3%	4 30.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67 (7)	54 (9)	60 (10)
Sex: Female, Male (Count of Participants)
Female	4 66.7%	5 71.4%	9 69.2%
Male	2 33.3%	2 28.6%	4 30.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cardiopulmonary Bypass	Extracorporeal Membrane Oxygenation
Arm/Group Description	There will be 40 patients randomized to cardiopulmonary bypass during lung transplantation. Cardiopulmonary Bypass: CPB is used during lung transplant procedure	There will be 40 patients randomized to ECMO during lung transplantation. Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure
Measure Participants	6	7
Mean (Standard Deviation) [number of pRBC transfusions]	4.8 (6.1)	6 (6.2)

Adverse Events

Time Frame	Up to hospital discharge
Arm/Group Title	Cardiopulmonary Bypass		Extracorporeal Membrane Oxygenation
Arm/Group Description	There will be 40 patients placed on cardiopulmonary bypass during lung transplantation. Cardiopulmonary Bypass: CPB is used during lung transplant procedure		There will be 40 patients placed on ECMO during lung transplantation. Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure
All Cause Mortality
	Cardiopulmonary Bypass		Extracorporeal Membrane Oxygenation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		1/7 (14.3%)
Serious Adverse Events
	Cardiopulmonary Bypass		Extracorporeal Membrane Oxygenation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Cardiopulmonary Bypass		Extracorporeal Membrane Oxygenation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.