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Failure to enroll
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiopulmonary Bypass | There will be 40 patients placed on cardiopulmonary bypass during lung transplantation. |
| |
| Extracorporeal Membrane Oxygenation | There will be 40 patients placed on ECMO during lung transplantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Membrane Oxygenation | Device | ECMO is used during lung transplant procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need for Blood Transfusion | Number of pRBC transfusion that resulted due to postoperative bleeding | 72 hours after surgery |
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Inclusion Criteria:
1. The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.
Exclusion Criteria:
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The study population will be all patients requiring cardiopulmonary support while undergoing lung transplantation at our institution.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Tong, M.D., M.B.A. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26291747 | Background | 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. | |
| 22944092 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiopulmonary Bypass | There will be 40 patients placed on cardiopulmonary bypass during lung transplantation. Cardiopulmonary Bypass: CPB is used during lung transplant procedure |
| FG001 | Extracorporeal Membrane Oxygenation | There will be 40 patients placed on ECMO during lung transplantation. Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiopulmonary Bypass | There will be 40 patients randomized to cardiopulmonary bypass during lung transplantation. Cardiopulmonary Bypass: CPB is used during lung transplant procedure |
| BG001 | Extracorporeal Membrane Oxygenation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Need for Blood Transfusion | Number of pRBC transfusion that resulted due to postoperative bleeding | Posted | Mean | Standard Deviation | number of pRBC transfusions | 72 hours after surgery |
|
Up to hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiopulmonary Bypass | There will be 40 patients placed on cardiopulmonary bypass during lung transplantation. Cardiopulmonary Bypass: CPB is used during lung transplant procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Tong, M. D. | Cleveland Clinic | 216-445-0807 | tongz@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2017 | Feb 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055031 | Primary Graft Dysfunction |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D015199 | Extracorporeal Membrane Oxygenation |
| D002315 | Cardiopulmonary Bypass |
| ID | Term |
|---|---|
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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| Cardiopulmonary Bypass | Device | CPB is used during lung transplant procedure |
|
| 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. |
| 25443002 | Background | 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. |
| 25583107 | Background | 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. |
There will be 40 patients randomized to ECMO during lung transplantation.
Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Extracorporeal Membrane Oxygenation | There will be 40 patients placed on ECMO during lung transplantation. Extracorporeal Membrane Oxygenation: ECMO is used during lung transplant procedure | 1 | 7 | 0 | 7 | 0 | 7 |
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |