Lung Transplant; Complications
Conditions
Keywords
Cardiopulmonary Bypass, Extracorporeal Membrane Oxygenation, Primary Graft Dysfunction, Hemorrhage, Mechanical Ventilator
Brief summary
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.
Interventions
DEVICEExtracorporeal Membrane Oxygenation
ECMO is used during lung transplant procedure
DEVICECardiopulmonary Bypass
CPB is used during lung transplant procedure
Sponsors
The Cleveland Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for Blood Transfusion | 72 hours after surgery | Number of pRBC transfusion that resulted due to postoperative bleeding |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiopulmonary Bypass There will be 40 patients randomized to cardiopulmonary bypass during lung transplantation.
Cardiopulmonary Bypass: CPB is used during lung transplant procedure | 6 |
| Extracorporeal Membrane Oxygenation There will be 40 patients randomized to ECMO during lung transplantation.
Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure | 7 |
| Total | 13 |
Baseline characteristics
| Characteristic | Cardiopulmonary Bypass | Extracorporeal Membrane Oxygenation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 7 | 54 years STANDARD_DEVIATION 9 | 60 years STANDARD_DEVIATION 10 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 1 / 7 |
| other Total, other adverse events | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
Primary
Need for Blood Transfusion
Number of pRBC transfusion that resulted due to postoperative bleeding
Time frame: 72 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cardiopulmonary Bypass | Need for Blood Transfusion | 4.8 number of pRBC transfusions | Standard Deviation 6.1 |
| Extracorporeal Membrane Oxygenation | Need for Blood Transfusion | 6 number of pRBC transfusions | Standard Deviation 6.2 |