Tranexamic Acid in HIp Fracture Surgery (THIF Study) (THIF)

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Fracture
• Intervention / Treatment: Drug: Tranexamic acid (Exacyl); Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Loire
    • Saint-etienne, Loire, France, 42055
      • CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Exacyl	Drug: Tranexamic acid (Exacyl); 15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery; Other Names: Exacyl
Placebo Comparator: 2; Physiologic serum	Drug: Placebo; NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Paul Zufferey, Doctor, CHU Saint-Etienne

Publications and helpful links

General Publications

• Zufferey PJ, Miquet M, Quenet S, Martin P, Adam P, Albaladejo P, Mismetti P, Molliex S; tranexamic acid in hip-fracture surgery (THIF) study. Tranexamic acid in hip fracture surgery: a randomized controlled trial. Br J Anaesth. 2010 Jan;104(1):23-30. doi: 10.1093/bja/aep314.

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): February 1, 2007
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: May 17, 2006
• First Submitted That Met QC Criteria: May 17, 2006
• First Posted (Estimate): May 18, 2006

Study Record Updates

• Last Update Posted (Estimate): June 11, 2009
• Last Update Submitted That Met QC Criteria: June 9, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: transfusion; tranexamic acid; fondaparinux; hip fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 0401129; DGS 2005-01094