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

• ClinicalTrials.gov Identifier: NCT02403596
• Recruitment Status: Completed
• First Posted: March 31, 2015
• Last Update Posted: January 9, 2018
• Sponsor: University Hospital, Brest
• Collaborator: Bayer
• Information provided by (Responsible Party): University Hospital, Brest

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Blood Loss After a Total Hip Replacement	Drug: Exacyl®; Other: Placebo of Exacyl®	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 231 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV
• Actual Study Start Date: October 20, 2015
• Actual Primary Completion Date: August 29, 2017
• Actual Study Completion Date: August 29, 2017

Arms and Interventions

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 Name: 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 Name: 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®

Outcome Measures

Primary Outcome Measures :

1. Total blood loss [ Time Frame: Between Day-1of surgery and Day+3 of surgery (5 days) ]
   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

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

France

HIA Clermont Tonnerre Brest

Brest, France, 29200

Polyclinique de Keraudren

Brest, France, 29287

CHRU Brest

Brest, France, 29609

CH Morlaix

Morlaix, France, 29672

Sponsors and Collaborators

University Hospital, Brest

Bayer

More Information

• Responsible Party: University Hospital, Brest
• ClinicalTrials.gov Identifier: NCT02403596
• Other Study ID Numbers: ESPER; RB15.005 ( Other Identifier: Brest UH )
• First Posted: March 31, 2015
• Last Update Posted: January 9, 2018
• Last Verified: January 2018

Keywords provided by University Hospital, Brest:

Hip replacement; rivaroxaban; exacyl; blood loss

Additional relevant MeSH terms:

Hemorrhage; Pathologic Processes; Tranexamic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants