Status:

COMPLETED

A Dose-response Study of Tranexamic Acid in Total Hip Arthroplasty

Lead Sponsor:

Centre Hospitalier Universitaire de Saint Etienne

Conditions:

Arthropathy of Hip

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. Ho...

Detailed Description

This dose-response study is a randomized double blind study with five groups of 30 patients each. Patients will be randomized to placebo, tranexamic acid (TXA) 300 mg, tranexamic acid (TXA) 500 mg, tr...

Eligibility Criteria

Inclusion

  • Patient requiring primary hip arthroplasty (less than 3 months)
  • Informed Consent from the patient or their legally authorized representative
  • Affiliation to French Social Security Healthcare system

Exclusion

  • Hip fracture of less than 3 months
  • Bilateral hip arthroplasty or anterior approach to hip arthroplasty
  • Haemorrhagic surgery in the previous 2 weeks
  • Contraindication to tranexamic acid
  • Contraindication to apixaban
  • Chronic use of anticoagulant
  • Pregnancy
  • Previous participation to this study

Key Trial Info

Start Date :

December 7 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 11 2025

Estimated Enrollment :

170 Patients enrolled

Trial Details

Trial ID

NCT03822793

Start Date

December 7 2023

End Date

July 11 2025

Last Update

November 26 2025

Active Locations (1)

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CHU Saint-Etienne

Saint-Etienne, France