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Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
HIA Clermont Tonnerre Brest
Brest, France
Polyclinique de Keraudren
Brest, France
CHRU Brest
Brest, France
CH Morlaix
Morlaix, France
Start Date
October 20, 2015
Primary Completion Date
August 29, 2017
Completion Date
August 29, 2017
Last Updated
January 9, 2018
231
ACTUAL participants
Exacyl®
DRUG
Placebo of Exacyl®
OTHER
Lead Sponsor
University Hospital, Brest
Collaborators
Data Source & Attribution
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