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Bypass vs. Ecmo in Lung Transplantation (BELT)

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Terminated

Conditions

Lung Transplant; Complications

Treatments

Device: Cardiopulmonary Bypass
Device: Extracorporeal Membrane Oxygenation

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

13 participants in 2 patient groups

Cardiopulmonary Bypass
Description:
There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.
Treatment:
Device: Cardiopulmonary Bypass
Extracorporeal Membrane Oxygenation
Description:
There will be 40 patients placed on ECMO during lung transplantation.
Treatment:
Device: Extracorporeal Membrane Oxygenation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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