Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 12:30 PM
Study NCT ID:
NCT00327106
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2006-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid in HIp Fracture Surgery (THIF Study)
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Study Overview
Official Title:
Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
Status:
COMPLETED
Status Verified Date:
2009-06
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:
THIF
Brief Summary:
The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.
Detailed Description:
Studies in hip and knee arthroplasty (scheduled surgery) have shown that tranexamic acid decreases allogeneic red blood cell transfusion. In hip fracture surgery, an emergent procedure, transfusion is frequent. Transfusion increases adverse events such as postoperative bacterial infection and venous thrombosis. The purpose of this study is to assess the efficacy of tranexamic acid, an anti-fibrinolytic agent, in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. The trial will also evaluate if the reduction in transfusion will be associated with less postoperative infection and without an increase in the thrombotic risk.
Patients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg IV at skin incision and three hours later or saline.Patients will receive fondaparinux for prophylaxis of venous thrombosis.
Patients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg IV at skin incision and three hours later or saline.Patients will receive fondaparinux for prophylaxis of venous thrombosis.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DGS 2005-01094 | None | None | View |