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NCT Number: NCT03822793

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

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.

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Key information

Conditions

Arthropathy of Hip

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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, tranexamic acid (TXA) 1000 mg or tranexamic acid (TXA) 3000 mg. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of tranexamic acid (TXA) plasma concentration as a predictor of intra and postoperative D-Dimer values.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

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.

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 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 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 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.

Primary outcomes

  1. haemoglobin decrease in the perioperative period

    Time frame: Day 1 to Day 4

    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

Secondary outcomes

  1. Tranexamic acid pharmacokinetics

    Time frame: Day 1

    For tranexamic acid pharmacokinetics, the outcome measure is the sampling of tranexamic blood concentration.

  2. D-Dimer kinetics

    Time frame: Day 1

    For tranexamic acid pharmacodynamics, the outcome is the sampling of D-Dimer levels.

  3. allogenic red blood cell transfusion

    Time frame: Day 1 to day 8

    For allogenic red blood cell transfusion, the outcome measure will be the percentage of patients that will receive the transfusion of at least one allogenic red blood cell unit in the perioperative period.

  4. severe anaemia

    Time frame: Day 1 to day 8

    For severe anaemia (defined as a level of haemoglobin <10 gram by deciliter), the outcome measure will be the percentage of patients that will have at least one value of haemoglobin <10 gram by deciliter in the perioperative period.

  5. incidence of symptomatic thrombotic events and death

    Time frame: Day 1 to day 8

    For the incidence of symptomatic thrombotic events and death, the outcome measure is a combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death.

  6. occurrence of a seizure

    Time frame: Day 8

    The endpoint is a combined criteria endpoint involving either the clinical observation of a generalized tonic-clonic seizure or a partial seizure or an epilepsy confirmed by an electroencephalogram interpreted by a neurologist blinded to the patient's inclusion group.

  7. number of adverse events

    Time frame: Day: 45

    collection in medical records the adverse events at 45 days after surgery :

    • venous thrombo-embolism / arterial
    • hematoma leading to modification of rehabilitation or requiring revision surgery
    • infections of superficial or deep surgical site

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Post-operative Hemoglobin Loss: A Phase 2 Randomized Double-blind Monocentric Study

Acronym: PRADO

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2019
Registry last updated
Nov 26, 2025

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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