Tranexamic Acid in HIp Fracture Surgery (THIF Study)

Hip Fracture Clinical Trial

— THIF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327106
• Other study ID #: 0401129
• Secondary ID: DGS 2005-01094
• Status: Completed
• Phase: Phase 3
• First received: May 17, 2006
• Last updated: June 9, 2009
• Start date: April 2005
• Est. completion date: February 2007

Study information

• Verified date: June 2009
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Intervention

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

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-etienne	Loire

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	post-operative major hemorrhage		day 8	Yes
Secondary	post-operative blood loss		untill day 8	No
Secondary	post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)		untill six weeks	No
Secondary	thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)		untill six weeks	Yes