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

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Blood Loss After a Total Hip Replacement

Treatments: Drug: Exacyl®; Other: Placebo of Exacyl®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02403596

RB15.005 (Other Identifier)

ESPER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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231 participants in 3 patient groups, including a placebo group

Group 1: Exacyl®: Standard treatment

Experimental group

Description:

Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 then 1g Exacyl® placebo at H+7 and H+11

Treatment:

Other: Placebo of Exacyl®

Drug: Exacyl®

Group 2: Exacyl®: Extended treatment

Experimental group

Description:

Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 / H+7 and H+11

Treatment:

Drug: Exacyl®

Group 3: Placebo

Placebo Comparator group

Description:

This group will receive a placebo of Exacyl®: 1g placebo of Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g placebo of Exacyl® at H+3 / H+7 and H+11

Treatment:

Other: Placebo of Exacyl®