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Tranexamic Acid in HIp Fracture Surgery (THIF Study)

Information source: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hip Fracture

Intervention: Tranexamic acid (Exacyl) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Centre Hospitalier Universitaire de Saint Etienne

Official(s) and/or principal investigator(s):
Paul Zufferey, Doctor, Principal Investigator, Affiliation: CHU Saint-Etienne

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.

Clinical Details

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

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

Primary outcome: number of patients receiving the transfusion of at least one unit of allogeneic red blood cell

Secondary outcome:

number of patients receiving the transfusion of at least one unit of allogeneic red blood cell

post-operative major hemorrhage

post-operative blood loss

post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)

thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Chu Saint-Etienne, Saint-etienne, Loire 42055, France
Additional Information

Starting date: April 2005
Last updated: June 9, 2009

Page last updated: August 23, 2015

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