Trial Outcomes & Findings for Bypass vs. Ecmo in Lung Transplantation (BELT) (NCT NCT03021538)
NCT ID: NCT03021538
Last Updated: 2020-03-24
Results Overview
Number of pRBC transfusion that resulted due to postoperative bleeding
Recruitment status
TERMINATED
Target enrollment
13 participants
Primary outcome timeframe
72 hours after surgery
Results posted on
2020-03-24
Participant Flow
Participant milestones
| Measure |
Cardiopulmonary Bypass
There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.
Cardiopulmonary Bypass: CPB is used during lung transplant procedure
|
Extracorporeal Membrane Oxygenation
There will be 40 patients placed on ECMO during lung transplantation.
Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cardiopulmonary Bypass
n=6 Participants
There will be 40 patients randomized to cardiopulmonary bypass during lung transplantation.
Cardiopulmonary Bypass: CPB is used during lung transplant procedure
|
Extracorporeal Membrane Oxygenation
n=7 Participants
There will be 40 patients randomized to ECMO during lung transplantation.
Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=13 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 7 • n=6 Participants
|
54 years
STANDARD_DEVIATION 9 • n=7 Participants
|
60 years
STANDARD_DEVIATION 10 • n=13 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=13 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 72 hours after surgeryNumber of pRBC transfusion that resulted due to postoperative bleeding
Outcome measures
| Measure |
Cardiopulmonary Bypass
n=6 Participants
There will be 40 patients randomized to cardiopulmonary bypass during lung transplantation.
Cardiopulmonary Bypass: CPB is used during lung transplant procedure
|
Extracorporeal Membrane Oxygenation
n=7 Participants
There will be 40 patients randomized to ECMO during lung transplantation.
Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure
|
|---|---|---|
|
Need for Blood Transfusion
|
4.8 number of pRBC transfusions
Standard Deviation 6.1
|
6 number of pRBC transfusions
Standard Deviation 6.2
|
Adverse Events
Cardiopulmonary Bypass
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Extracorporeal Membrane Oxygenation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place