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Tranexamic Acid in HIp Fracture Surgery (THIF Study)

C

Centre Hospitalier Universitaire de Saint Etienne

Status and phase

Completed
Phase 3

Conditions

Hip Fracture

Treatments

Drug: Tranexamic acid (Exacyl)
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00327106
0401129
DGS 2005-01094

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

110 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Description:
Exacyl
Treatment:
Drug: Tranexamic acid (Exacyl)
2
Placebo Comparator group
Description:
Physiologic serum
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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