An observational study in Lung Transplant; Complications, sponsored by The Cleveland Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-24.
Sponsored by The Cleveland Clinic · Observational
This study seeks to compare outcomes of 2 different methods of cardiopulmonary support during lung transplant surgeries.
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.
The Cleveland Clinic is the lead sponsor of 819 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.
Exclusion Criteria:
There will be 40 patients placed on cardiopulmonary bypass during lung transplantation.
Device: Cardiopulmonary Bypass
There will be 40 patients placed on ECMO during lung transplantation.
Device: Extracorporeal Membrane Oxygenation
ECMO is used during lung transplant procedure
CPB is used during lung transplant procedure
Need for Blood Transfusion
Number of pRBC transfusion that resulted due to postoperative bleeding
Time frame: 72 hours after surgery
| Milestone | Cardiopulmonary Bypass | Extracorporeal Membrane Oxygenation |
|---|---|---|
| Started | 6 | 7 |
| Completed | 6 | 7 |
| Not completed | 0 | 0 |
Number of pRBC transfusion that resulted due to postoperative bleeding
| number of pRBC transfusions | Cardiopulmonary Bypass | Extracorporeal Membrane Oxygenation |
|---|---|---|
| Need for Blood Transfusion | 4.8 ± 6.1 | 6 ± 6.2 |
Collected over Up to hospital discharge. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cardiopulmonary Bypass | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Extracorporeal Membrane Oxygenation | 1/7 (14.3%) | 0/7 (0%) | 0/7 (0%) |
| Age, Categorical(Participants) | Cardiopulmonary Bypass | Extracorporeal Membrane Oxygenation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 6 | 9 |
| >=65 years | 3 | 1 | 4 |
| Age, Continuous(years) | Cardiopulmonary Bypass | Extracorporeal Membrane Oxygenation | Total |
|---|---|---|---|
| Mean | 67 ± 7 | 54 ± 9 | 60 ± 10 |
| Sex: Female, Male(Participants) | Cardiopulmonary Bypass | Extracorporeal Membrane Oxygenation | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 2 | 2 | 4 |
| Race and Ethnicity Not Collected(Participants) | Cardiopulmonary Bypass | Extracorporeal Membrane Oxygenation | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Plan to share: No
This study is terminated, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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