Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079508
Status:
COMPLETED
Last Update Posted:
2011-11-10
First Post:
2004-03-09
Brief Title:
Angiomax in Patients With HITHITTS Type II Undergoing CPB
Sponsor:
The Medicines Company
Organization:
The Medicines Company
Study Overview
Official Title:
A Phase III Study of Angiomax Bivalirudin in Patients With HITHITTS Type II Undergoing Cardiac Surgery on Cardiopulmonary Bypass CPB
Status:
COMPLETED
Status Verified Date:
2011-11
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:
HITTS
Brief Summary:
The purpose of this study is to demonstrate that in patients with heparin-induced thrombocytopenia HITheparin-induced thrombocytopenia and thrombosis syndrome HITTS Type II undergoing cardiac surgery on cardiopulmonary bypass CPB Angiomax is a safe and effective anticoagulant
Detailed Description:
An open-label prospective multicenter single-arm study with a historical reference cohort of similarly identified HITHITTS patients from participating institutions that underwent cardiac surgery on CPB with alternative anticoagulation regimens during the period of approximately 12 months prior to initiation of the first patient into this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHOOSE-On | None | None | None |