Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06615492
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Routine vs On-demand ECMO for Lung Transplantation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
RoutinE Versus On-demand Intraoperative Extracorporeal Membrane Oxygenation ECMO During LUng TransplantatION REVOLUTION
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVOLUTION
Brief Summary:
Lung transplantation is a complex procedure performed in patients with terminal lung disease The transplant procedure stresses the patients heart and lungs which are already taxed by the underlying disease process The heart-lung machine is occasionally used to support the patient and ensure adequate oxygen supply to other organs during the operation It can be used routinely in all patients or selectively in patients who exhibit reduced oxygen supply to the remaining organs This process known as cardiopulmonary bypass CPB pumps blood out of the body to a heart-lung machine that removes carbon dioxide and returns oxygen-filled blood to the body
Although using the CPB increases the risk of bleeding infection and coagulation complications it should still be considered in high-risk patients to compensate for more severe complications such as kidney failure and stroke caused by a lack of cardiopulmonary support Extracorporeal membrane oxygenation ECMO is a recently developed CPB variation associated with fewer bleeding complications It has recently replaced the traditional heart-lung machine as the preferred method of cardiopulmonary support during lung transplantation Since ECMO is associated with fewer complications than standard CPB many centers have increased their use of ECMO during lung transplantation Some have even employed it routinely However there remains significant debate on how often it should be used
Therefore the studys main objective is to compare the two approaches in lung transplantation ie routine use versus selective use and to determine if one approach is preferable to the other
Although using the CPB increases the risk of bleeding infection and coagulation complications it should still be considered in high-risk patients to compensate for more severe complications such as kidney failure and stroke caused by a lack of cardiopulmonary support Extracorporeal membrane oxygenation ECMO is a recently developed CPB variation associated with fewer bleeding complications It has recently replaced the traditional heart-lung machine as the preferred method of cardiopulmonary support during lung transplantation Since ECMO is associated with fewer complications than standard CPB many centers have increased their use of ECMO during lung transplantation Some have even employed it routinely However there remains significant debate on how often it should be used
Therefore the studys main objective is to compare the two approaches in lung transplantation ie routine use versus selective use and to determine if one approach is preferable to the other
Detailed Description:
This study compares two approaches to intraoperative cardiopulmonary support during lung transplantation routine cardiopulmonary support with extracorporeal membrane oxygenation ECMO versus selective use Despite recent improvements in lung transplant outcomes postoperative complications are common Intraoperative hemodynamic management is vital to the success of lung transplantation Many centers including all four Canadian centers use ECMO to provide intraoperative support However lung transplantation without cardiopulmonary support may be possible in certain patients In such patients the transplant may be started without ECMO ECMO may be initiated on-demand if hemodynamic embarrassment or hypoxia occurs Conversely the opposite approach would be routinely conducting all lung transplants using ECMO The current practice in many centers is to use ECMO selectively By extension the investigators believe that more liberal use of intraoperative ECMO will produce less intraoperative hemodynamic instability and hypoxia However it is unclear the extent of ECMO use necessary to improve the incidence of postoperative hypoperfusion-related complications Should ECMO be used routinely in all patients or selectively based on the intraoperative course The study is a prospective randomized controlled trial with two treatment arms routine support with ECMO versus selective on-demand support with ECMO Study population Inclusion and exclusion criteria All patients 18 years of age or older undergoing lung transplantation will be screened for participation We will exclude patients who require intraoperative ECMO multi-organ transplants and retransplantation Arms and Interventions On-demand ECMO The transplant will be planned without cardiopulmonary support in this group Intraoperative ECMO will be employed if there is an inability to maintain adequate organ perfusion and oxygen delivery despite resuscitation Routine ECMO Routine intraoperative ECMO in all patients regardless of hemodynamic status Primary outcome Intensive care unit ICU-free days in the first 28 days post-lung transplant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None