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Tranexamic Acid in HIp Fracture Surgery (THIF Study)
This study has been terminated.
( all patients was inclued and ended of follow-up )
First Received: May 17, 2006   Last Updated: August 1, 2007   History of Changes
Sponsored by: Centre Hospitalier Universitaire de Saint Etienne
Information provided by: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00327106
  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 III

MedlinePlus related topics: Blood Transfusion and Donation Fractures Hip Injuries and Disorders Hip Replacement Surgery
Drug Information available for: Tranexamic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Double-Blind, Efficacy Study, Parallel Assignment, Placebo Control, Randomized, Treatment
Official Title: Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.

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 peripherial arterial thrombosis) [ Time Frame: untill six weeks ]

Enrollment: 110
Study Start Date: April 2005
Study Completion Date: February 2007
Arms Assigned Interventions
1: Active Comparator
Exacyl
Drug: Tranexamic acid (Exacyl)
15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
2: Placebo Comparator
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00327106

Locations
France, Loire
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

No publications provided

Study ID Numbers: 0401129, DGS 2005-01094
Study First Received: May 17, 2006
Last Updated: August 1, 2007
ClinicalTrials.gov Identifier: NCT00327106     History of Changes
Health Authority: France: Afssaps - French Health Products Safety Agency;   France: French Data Protection Authority

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

Study placed in the following topic categories:
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Fondaparinux
Tranexamic Acid
Hemorrhage
Hemostatics
Org 31540
Hip Fractures
Femoral Fractures
Antiplasmin
Fibrin Modulating Agents
Antifibrinolytic Agents
Leg Injuries

Additional relevant MeSH terms:
Antifibrinolytic Agents
Coagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Tranexamic Acid
Hip Injuries
Pharmacologic Actions
Hemostatics
Hip Fractures
Femoral Fractures
Fibrin Modulating Agents
Therapeutic Uses
Leg Injuries

ClinicalTrials.gov processed this record on March 16, 2009