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Tranexamic Acid in HIp Fracture Surgery (THIF Study) (THIF)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327106
First Posted: May 18, 2006
Last Update Posted: June 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
  Purpose
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.

Condition Intervention Phase
Hip Fracture Drug: Tranexamic acid (Exacyl) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • number of patients receiving the transfusion of at least one unit of allogeneic red blood cell [ Time Frame: between the begining of surgery (day 1) and the eighth post-operative day (day 8) ]

Secondary Outcome Measures:
  • number of patients receiving the transfusion of at least one unit of allogeneic red blood cell [ Time Frame: 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) ]
  • post-operative major hemorrhage [ Time Frame: day 8 ]
  • post-operative blood loss [ Time Frame: untill day 8 ]
  • post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection) [ Time Frame: untill six weeks ]
  • thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis) [ Time Frame: untill six weeks ]

Enrollment: 110
Study Start Date: April 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Exacyl
Drug: Tranexamic acid (Exacyl)
15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
Other Name: Exacyl
Placebo Comparator: 2
Physiologic serum
Drug: Placebo
NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327106


Locations
France
Chu Saint-Etienne
Saint-etienne, Loire, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Paul Zufferey, Doctor CHU Saint-Etienne
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clément CAILLAUX, Centre Hospitalier Universitaire de Saint-Etienne
ClinicalTrials.gov Identifier: NCT00327106     History of Changes
Other Study ID Numbers: 0401129
DGS 2005-01094
First Submitted: May 17, 2006
First Posted: May 18, 2006
Last Update Posted: June 11, 2009
Last Verified: June 2009

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
hip fracture
transfusion
tranexamic acid
fondaparinux

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants