Bypass vs. Ecmo in Lung Transplantation (BELT)

NCT03021538 | Terminated Results

• 1 other identifier: 17-166
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Transplant; Complications

Keywords

Cardiopulmonary Bypass; Extracorporeal Membrane Oxygenation; Primary Graft Dysfunction; Hemorrhage; Mechanical Ventilator

Outcome Measures

Primary Outcomes (1)

• Need for Blood Transfusion

  Number of pRBC transfusion that resulted due to postoperative bleeding

  72 hours after surgery

Study Arms (2)

Cardiopulmonary Bypass

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

Device: Cardiopulmonary Bypass

Extracorporeal Membrane Oxygenation

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

Device: Extracorporeal Membrane Oxygenation

Interventions

Extracorporeal Membrane Oxygenation DEVICE

ECMO is used during lung transplant procedure

Extracorporeal Membrane Oxygenation

Cardiopulmonary Bypass DEVICE

CPB is used during lung transplant procedure

Cardiopulmonary Bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.

You may qualify if:

• \. The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.

You may not qualify if:

• Patients undergoing concomitant cardiac operations with indication for obligate use of cardiopulmonary bypass
• 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
• Patients with high likelihood of significant pleural bleeding that will require returning the blood back into the cardiotomy reservoir
• Patients bridged to transplant with ECMO
• Cystic fibrosis/bronchiectasis/resistant infection patients where surgeon will need to remove both lungs prior to implantation
• Patients who the surgeon feels would be better served with CPB rather than ECMO- These patients will be entered into a registry and followed.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (4)

• 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.

  PMID: 26291747 BACKGROUND

• 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.

  PMID: 22944092 BACKGROUND

• 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.

  PMID: 25443002 BACKGROUND

• 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.

  PMID: 25583107 BACKGROUND

MeSH Terms

Conditions

Primary Graft Dysfunction; Hemorrhage

Interventions

Extracorporeal Membrane Oxygenation; Cardiopulmonary Bypass

Condition Hierarchy (Ancestors)

Reperfusion Injury; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative

Results Point of Contact

• Title: Michael Tong, M. D.
• Organization: Cleveland Clinic

tongz@ccf.org

216-445-0807

Study Officials

• Michael Tong, M.D., M.B.A.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiac Surgeon

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 16, 2017
• Study Start: April 17, 2017
• Primary Completion: January 24, 2019
• Study Completion: January 24, 2019
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)