Blood-sparing During Hip Prosthesis Surgery With Exacyl® in Patients Treated With Rivaroxaban

In 2011, 140 000 total hip replacements were performed and bleeding remains one of the major complications responsible for significant morbidity. This study will evaluate a new treatment to prevent bleeding due to this surgery. Indeed, the tranexamic acid (Exacyl) will be used in two modes of administration (standard or extended) versus placebo combined with a Rivaroxaban treatment at a dose of 10 mg / day for 35 days.

Patients will be randomized (exacyl standard vs exacyl extended vs. placebo) and will be followed for 3 months.

Inclusion criteria

• Over 18 years of age
• Scheduled to undergo elective non-traumatic primary cementless THA
• Having given written informed consent to participate in the trial
• Covered by Social Security

Exclusion criteria

• Rapidly destructive arthrosis of the hip
• History of prior surgery on the operative hip
• Contraindications to the use of tranexamic acid:

• Ischaemic artery disease (angina pectoris, myocardial infarction, acute coronary syndrome or stroke)
• History of venous thromboembolism
• Severe renal impairment, i.e. with clearance < 30mL/mn
• Epilepsy or history of convulsions
• Contraindications to the use of rivaroxaban

• Severe renal failure (clearance <30ml / min)
• Cirrhotic patients with Child Pugh B
• Pregnancy and breastfeeding
• Cognitive disorder that precludes giving informed consent
• Refusal to participate in trial
• Allergy to either of the trial treatments
• On-going prophylaxis of thrombosis using an agent other than rivaroxaban
• On-going platelet aggregation inhibitor at a dose exceeding 125 mg daily