Bypass vs. Ecmo in Lung Transplantation (BELT)

NCT ID: NCT03021538

Last Updated: 2020-03-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-17

Study Completion Date

2019-01-24

Brief Summary

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

Detailed Description

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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.

Conditions

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Lung Transplant; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiopulmonary Bypass

There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.

Cardiopulmonary Bypass

Intervention Type DEVICE

CPB is used during lung transplant procedure

Extracorporeal Membrane Oxygenation

There will be 40 patients placed on ECMO during lung transplantation.

Extracorporeal Membrane Oxygenation

Intervention Type DEVICE

ECMO is used during lung transplant procedure

Interventions

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Extracorporeal Membrane Oxygenation

ECMO is used during lung transplant procedure

Intervention Type DEVICE

Cardiopulmonary Bypass

CPB is used during lung transplant procedure

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Michael Zhen-Yu Tong, MD

Cardiac Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Tong, M.D., M.B.A.

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26291747 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22944092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25443002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25583107 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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17-166

Identifier Type: -

Identifier Source: org_study_id

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