Tranexamic Acid in HIp Fracture Surgery (THIF Study)

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00327106
First received: May 17, 2006
Last updated: June 9, 2009
Last verified: June 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • post-operative major hemorrhage [ Time Frame: day 8 ] [ Designated as safety issue: Yes ]
  • post-operative blood loss [ Time Frame: untill day 8 ] [ Designated as safety issue: No ]
  • post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection) [ Time Frame: untill six weeks ] [ Designated as safety issue: No ]
  • thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis) [ Time Frame: untill six weeks ] [ Designated as safety issue: Yes ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Centre Hospitalier Universitaire de Saint Etienne

Additional 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
Study First Received: May 17, 2006
Last Updated: June 9, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

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
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014