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

NCT03822793 | Completed Phase 2 DMC

• 3 other identifiers: 18CH0522018-004552-372022-502532-38-01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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. However the optimal dose to administer is unknown.

Conditions

Arthropathy of Hip

Keywords

tranexamic acid (TXA); arthroplasty; hip; Exacyl

Outcome Measures

Primary Outcomes (1)

• haemoglobin decrease in the perioperative period

  Percentage of haemoglobin change in the perioperative period. It requires the sampling of haemoglobin just before surgery (Day 1) and on the fourth postoperative day

  Day 1 to Day 4

Secondary Outcomes (7)

• Tranexamic acid pharmacokinetics

  Day 1

• D-Dimer kinetics

  Day 1

• allogenic red blood cell transfusion

  Day 1 to day 8

• severe anaemia

  Day 1 to day 8

• incidence of symptomatic thrombotic events and death

  Day 1 to day 8

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Patient will be included in this group by randomization and they will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision.

Drug: Placebo

Group 1: perfusion of 300 mg Exacyl

EXPERIMENTAL

Patient will be included in the group 2 by randomization and they 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 1: perfusion of 300 mg Exacyl

Group 2: perfusion of 500 mg Exacyl

EXPERIMENTAL

Patient will be included in the group 2 by randomization and they 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 2: perfusion of 500 mg Exacyl

Group 3: perfusion of 1000 mg Exacyl

EXPERIMENTAL

Patient will be included in the group 3 by randomization and they 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 3: perfusion of 1000 mg Exacyl

Group 4: perfusion of 3000 mg Exacyl

EXPERIMENTAL

Patient will be included in the group 4 by randomization and they will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.

Drug: Group 4: perfusion of 3000 mg Exacyl

Interventions

Placebo DRUG

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

Placebo

Group 1: perfusion of 300 mg Exacyl DRUG

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

Group 1: perfusion of 300 mg Exacyl

Group 2: perfusion of 500 mg Exacyl DRUG

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

Group 2: perfusion of 500 mg Exacyl

Group 3: perfusion of 1000 mg Exacyl DRUG

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

Group 3: perfusion of 1000 mg Exacyl

Group 4: perfusion of 3000 mg Exacyl DRUG

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

Group 4: perfusion of 3000 mg Exacyl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

Related Publications (1)

• Zufferey PJ, Barrat E, Deygas B, Lanoiselee J, Ollier E. Dose-effect relationship of intravenous tranexamic acid on perioperative haemoglobin drop in total hip arthroplasty (PRADO study): study protocol for a randomised, double-blind, placebo-controlled, dose-response study. BMJ Open. 2025 Dec 3;15(12):e100265. doi: 10.1136/bmjopen-2025-100265.

  PMID: 41338640 DERIVED

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Julien LANOISELEE, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: randomized double blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 30, 2019
• Study Start: December 7, 2023
• Primary Completion: April 21, 2025
• Study Completion: July 11, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)