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

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss After a Total Hip Replacement
• Intervention / Treatment: Drug: Exacyl®; Other: Placebo of Exacyl®

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.

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHRU Brest
  • Brest, France, 29200
    • HIA Clermont Tonnerre Brest
  • Brest, France, 29287
    • Polyclinique de Keraudren
  • Morlaix, France, 29672
    • CH Morlaix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Exacyl®: Standard treatment; 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	Drug: Exacyl®; Other Names: Tranexamic acid; Other: Placebo of Exacyl®
Experimental: Group 2: Exacyl®: Extended treatment; 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	Drug: Exacyl®; Other Names: Tranexamic acid
Placebo Comparator: Group 3: Placebo; 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	Other: Placebo of Exacyl®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total blood loss	Total Blood Loss (TBL) in mL of red blood cells, calculated using Mercuriali's formula at 100% haematocrit (Ht) and then converted to mL of blood at 35% Ht	Between Day-1of surgery and Day+3 of surgery (5 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in haemoglobin level (g/dL) between Day-1 and Day+3	5 days
Maximum difference in haemoglobin level (g/dL) from D-1 up to D+3	5 days
Number of transfusions and volume in mL performed during hospitalisation (operating theatre and unit)	5 days
Major haemorrhagic events, clinically significant non-major haemorrhagic events and minor haemorrhagic events	3 month
Surgical revision	3 month
Occurrence of venous or arterial thromboembolic events	3 month
Local infectious complications	3 month
Death due to any cause and death due to cardiovascular cause	3 month

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2015
• Primary Completion (Actual): August 29, 2017
• Study Completion (Actual): August 29, 2017

Study Registration Dates

• First Submitted: March 13, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Actual): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 8, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: blood loss; Hip replacement; rivaroxaban; exacyl
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: ESPER; RB15.005 (Other Identifier: Brest UH)