Tranexamic Acid in HIp Fracture Surgery (THIF Study)

Phase 3

Completed

• Conditions: Hip Fracture
• Interventions: Drug: Tranexamic acid (Exacyl); Drug: Placebo

• Registration Number: NCT00327106
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-05-17
• Study First Submitted QC: 2006-05-17
• Study First Posted: 2006-05-18
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-09
• Last Update Posted: 2009-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Patient requiring surgery for an isolated hip fracture of less than 48 hours

Exclusion Criteria

• Contraindication to tranexamic acid
• Contraindication to fondaparinux
• Contraindication to general anesthesia associated with a femoral nerve block
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tranexamic acid (Exacyl)	Exacyl
2	Placebo	Physiologic serum

Primary Outcome Measures

Name	Time	Method
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell	between the begining of surgery (day 1) and the eighth post-operative day (day 8)

Secondary Outcome Measures

Name	Time	Method
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell	between the administration of fondaparinux for venous thrombosis prophylaxis(8 hours after end of surgery on day 1) and the eighth post-operative day (day 8)
post-operative major hemorrhage	day 8
post-operative blood loss	untill day 8
post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)	untill six weeks
thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)	untill six weeks

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 Saint-etienne, Loire, France