Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-03 @ 3:33 AM
Study NCT ID:
NCT03090893
Status:
WITHDRAWN
Last Update Posted:
2018-09-10
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
A Pilot Study, Prospective, Non-Randomized, Non-Blinded, Single-Center Study Evaluating the Response of Continuous Recombinant Antithrombin (ATryn) Infusion in Postcardiotomy ECMO Patients
Status:
WITHDRAWN
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI passed away
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study will be to prospectively evaluate the response of a continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and maintain the AT activity within a specified range in adult patients that require extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac surgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: