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

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

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.

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