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Tranexamic Acid in HIp Fracture Surgery (THIF Study)

Sponsor
Centre Hospitalier Universitaire de Saint Etienne (Other)
Overall Status
Completed
CT.gov ID
NCT00327106
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
22
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic acid (Exacyl)
  • Drug: Placebo
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
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.
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Feb 1, 2007
Actual Study Completion Date :
Feb 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Exacyl

Drug: Tranexamic acid (Exacyl)
15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
Other Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. number of patients receiving the transfusion of at least one unit of allogeneic red blood cell [between the begining of surgery (day 1) and the eighth post-operative day (day 8)]

    Secondary Outcome Measures

    1. number of patients receiving the transfusion of at least one unit of allogeneic red blood cell [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)]

    2. post-operative major hemorrhage [day 8]

    3. post-operative blood loss [untill day 8]

    4. post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection) [untill six weeks]

    5. thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis) [untill six weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00327106
    Other Study ID Numbers:
    • 0401129
    • DGS 2005-01094
    First Posted:
    May 18, 2006
    Last Update Posted:
    Jun 11, 2009
    Last Verified:
    Jun 1, 2009
    Keywords provided by , ,
    hip fracture
    transfusion
    tranexamic acid
    fondaparinux
    Additional relevant MeSH terms:
    Fractures, Bone
    Hip Fractures
    Tranexamic Acid

    Study Results

    No Results Posted as of Jun 11, 2009