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

NCT03822793 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-11-26

No results posted yet for this study

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. However the optimal dose to administer is unknown.

Conditions

  • Arthropathy of Hip

Interventions

DRUG

Placebo

Patient will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision.

DRUG

Group 1: perfusion of 300 mg Exacyl

Patient will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.

DRUG

Group 2: perfusion of 500 mg Exacyl

Patient will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.

DRUG

Group 3: perfusion of 1000 mg Exacyl

Patient will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.

DRUG

Group 4: perfusion of 3000 mg Exacyl

Patient will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Julien LANOISELEE, MD · CHU SAINT-ETIENNE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2025-04-21
Completion
2025-07-11

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03822793 on ClinicalTrials.gov