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Tranexamic Acid in HIp Fracture Surgery (THIF Study)

2014-08-27 03:44:33 | BioPortfolio

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.

Study Design

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

Conditions

Hip Fracture

Intervention

Tranexamic acid (Exacyl), Placebo

Location

Chu Saint-Etienne
Saint-etienne
Loire
France
42055

Status

Completed

Source

Centre Hospitalier Universitaire de Saint Etienne

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:44:33-0400

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Medical and Biotech [MESH] Definitions

Antifibrinolytic hemostatic used in severe hemorrhage.

Implantable fracture fixation devices attached to bone fragments with screws to bridge the fracture gap and shield the fracture site from stress as bone heals. (UMDNS, 1999)

Fracture in the proximal half of the shaft of the ulna, with dislocation of the head of the radius.

The use of metallic devices inserted into or through bone to hold a fracture in a set position and alignment while it heals.

Fracture of the lower end of the radius in which the lower fragment is displaced posteriorly.

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