NCT00327106

Tranexamic Acid in HIp Fracture Surgery (THIF Study)

Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Fracture

Interventions

Type	Name	Description
DRUG	Tranexamic acid (Exacyl)	15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
DRUG	Placebo	NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.

Timeline

• Start date: 2005-04-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2006-05-18
• Last updated: 2009-06-11

Locations

1 site across 1 country: France