Ignite Creation Date:
2024-05-06 @ 6:06 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05547698
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2022-09-15
Brief Title:
A Study of Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Venoarterial ECMO vs Off-Pump Bilateral Orthotopic Lung Transplantation VIP BOLT Trial A Multicenter Prospective Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to compare the technique of performing bilateral lung transplantation off-pump vs venoarterial ECMO VA ECMO The goal of the trial is to determine which technique has lower rates of primary graft dysfunction
Detailed Description:
The Investigators of the Extracorporeal Life Support Registry in Lung Transplantation ECLS Registry has studied the impact of the type of intraoperative extracorporeal life support on primary graft dysfunction PGD after lung transplantation LTx in an international registry The investigators have demonstrated that severe PGD at 48-72 hours is greater when LTx is performed using cardiopulmonary bypass CPB 43 when compared to veno-arterial VA ECMO However PGD after VA ECMO remained high 29 when compared to off-pump 12 Conversely there are retrospective series showing that when compared to off-pump technique VA ECMO has reduced PGD rates and improved survival Because selection bias and unknown confounders in retrospective studies could have been the cause of these conflicting results part of the ECLS Registry Investigators are committed to a prospective multicenter randomized trial comparing off-pump versus VA ECMO LTx
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None