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

Centre Hospitalier Universitaire de Saint Etienne170 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

170

Conditions

Arthropathy of Hip

Interventions

PlaceboDRUG

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 ExacylDRUG

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 ExacylDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU Saint-Etienne

Saint-Etienne, France

Outcomes

Primary Outcomes

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

Time frame: Day 1 to Day 4

Secondary Outcomes

Tranexamic acid pharmacokinetics

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

Time frame: Day 1

D-Dimer kinetics

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

Time frame: Day 1

allogenic red blood cell transfusion

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.

Time frame: Day 1 to day 8

severe anaemia

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.

Time frame: Day 1 to day 8

incidence of symptomatic thrombotic events and death

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.

Time frame: Day 1 to day 8

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.