Clinical trial NCT02403596: Blood-sparing During Hip Prosthesis Surgery With Exacyl® in Patients Treated With Rivaroxaban
Official title: Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blood Loss After a Total Hip Replacement
Keywords: Hip replacement
rivaroxaban
exacyl
blood loss
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2015-03-31
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Total blood loss
timeFrame: Between Day-1of surgery and Day+3 of surgery (5 days)
Secondary outcomes:
measure: Difference in haemoglobin level (g/dL) between Day-1 and Day+3
timeFrame: 5 days
measure: Maximum difference in haemoglobin level (g/dL) from D-1 up to D+3
timeFrame: 5 days
measure: Number of transfusions and volume in mL performed during hospitalisation (operating theatre and unit)
timeFrame: 5 days
measure: Major haemorrhagic events, clinically significant non-major haemorrhagic events and minor haemorrhagic events
timeFrame: 3 month
measure: Surgical revision
timeFrame: 3 month
measure: Occurrence of venous or arterial thromboembolic events
timeFrame: 3 month
measure: Local infectious complications
timeFrame: 3 month
measure: Death due to any cause and death due to cardiovascular cause
timeFrame: 3 month
Other outcomes:
Locations:
city: Brest
country: France
facility: HIA Clermont Tonnerre Brest
city: Brest
country: France
facility: Polyclinique de Keraudren
city: Brest
country: France
facility: CHRU Brest
city: Morlaix
country: France
facility: CH Morlaix
Study officials:
References: