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Completed

NCT Number: NCT00327106

Tranexamic Acid in HIp Fracture Surgery (THIF Study)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu Saint-Etienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic acid (Exacyl)

Drug

15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery

Other names: Exacyl

Placebo

Drug

NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. post-operative major hemorrhage

    Time frame: day 8

  3. post-operative blood loss

    Time frame: untill day 8

  4. post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)

    Time frame: untill six weeks

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

    Time frame: untill six weeks

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.

Acronym: THIF

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 18, 2006
Registry last updated
Jun 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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