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

• Status: Completed
• Trial end date: 2017-08-29
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood loss using two dosage regimens (standard and extended) after a surgery during total hip arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for prophylaxis of thrombosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Brest
• Collaborator: Bayer
• Treatments: Rivaroxaban; Tranexamic Acid

Criteria

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