Lung Transplant; ComplicationsBELTNCT03021538

Bypass vs. Ecmo in Lung Transplantation (BELT)

An observational study of Lung Transplant; Complications, run by The Cleveland Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Transplant; Complications
What is being tested?: Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass
Type of treatment: Medical device
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 17 Apr 2017to 24 Jan 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Lung Transplant; Complications
Being tested: Extracorporeal Membrane Oxygenation, Cardiopulmonary Bypass
Keywords: Cardiopulmonary Bypass, Extracorporeal Membrane Oxygenation, Primary Graft Dysfunction, Hemorrhage, Mechanical Ventilator
Medical subject headings: Primary Graft Dysfunction, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Extracorporeal Membrane OxygenationDevice
ECMO is used during lung transplant procedure
Cardiopulmonary BypassDevice
CPB is used during lung transplant procedure

Study groups in NCT03021538
Study group	Role	What they receive
Cardiopulmonary Bypass		There will be 40 patients placed on cardiopulmonary bypass during lung transplantation. Receives: Device: Cardiopulmonary Bypass
Extracorporeal Membrane Oxygenation		There will be 40 patients placed on ECMO during lung transplantation. Receives: Device: Extracorporeal Membrane Oxygenation

What is being measured

The primary outcome is the main question the study is designed to answer.

Need for Blood Transfusion
Number of pRBC transfusion that resulted due to postoperative bleeding
Measured: 72 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Apr 201724 Jan 2019

First posted16 Jan 2017 (estimated)
Study start17 Apr 2017
Primary completion24 Jan 2019
Study completion24 Jan 2019

Why it stopped: Failure to enroll

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Lung Transplant; ComplicationsStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03021538
Sponsor's protocol ID: 17-166
Acronym: BELT
Status last verified: Mar 2020
First submitted: 12 Jan 2017
Last updated: 24 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 26291747
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.
PubMed 22944092
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.
PubMed 25443002
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.
PubMed 25583107

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lung Transplant; Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Clinical Trial of Intraoperative Extracorporeal Membrane Oxygenation (ECMO) Versus Cardiopulmonary Bypass (CPB) in Lung Transplantation
ClinicalTrials.gov ID: NCT03021538
Acronym / sponsor ID: BELT / 17-166
Conditions: Lung Transplant; Complications
Keywords: Cardiopulmonary Bypass, Extracorporeal Membrane Oxygenation, Primary Graft Dysfunction, Hemorrhage, Mechanical Ventilator
Study type: Observational
Recruitment status: TerminatedReason stopped: Failure to enroll
Enrolment: 13 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: 17 Apr 2017 (actual)
Primary completion: 24 Jan 2019 (actual)
Study completion: 24 Jan 2019 (actual)
First posted: 16 Jan 2017 (estimated)
Results: Posted 24 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Cardiopulmonary Bypass	–	Device: Cardiopulmonary BypassThere will be 40 patients placed on cardiopulmonary bypass during lung transplantation.
Extracorporeal Membrane Oxygenation	–	Device: Extracorporeal Membrane OxygenationThere will be 40 patients placed on ECMO during lung transplantation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.

Key inclusion criteria (1 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Extracorporeal Membrane OxygenationECMO is used during lung transplant procedure	Device	Extracorporeal Membrane Oxygenation
Cardiopulmonary BypassCPB is used during lung transplant procedure	Device	Cardiopulmonary Bypass

Primary outcome

Need for Blood Transfusion
Time frame: 72 hours after surgery
Number of pRBC transfusion that resulted due to postoperative bleeding

Results and safety

Results posted to the registry on 24 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cardiopulmonary Bypass	6	6
Extracorporeal Membrane Oxygenation	7	7

Primary outcome: Need for Blood Transfusion

Time frame: 72 hours after surgery. Mean (Standard Deviation). Unit: number of pRBC transfusions

Measure	Cardiopulmonary Bypass n = 6	Extracorporeal Membrane Oxygenation n = 7
Value	4.8 (6.1)	6 (6.2)

Adverse events

Time frame: Up to hospital discharge. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cardiopulmonary Bypass	0 of 6 (0%)	0 of 6 (0%)	0 of 6
Extracorporeal Membrane Oxygenation	0 of 7 (0%)	0 of 7 (0%)	1 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26291747Hoechter 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.
Background: PubMed 22944092Ius 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.
Background: PubMed 25443002Bermudez 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.
Background: PubMed 25583107Machuca 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Transplant; Complications, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for Blood Transfusion (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03021538, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.