NCT02403596

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

Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 231 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Blood Loss After a Total Hip Replacement

Interventions

Type	Name	Description
DRUG	Exacyl®
OTHER	Placebo of Exacyl®

Timeline

• Start date: 2015-10-20
• Primary completion: 2017-08-29
• Completion: 2017-08-29
• First posted: 2015-03-31
• Last updated: 2018-01-09

Locations

4 sites across 1 country: France