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 cellpost-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
|