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

Phase 3

Completed

• Conditions: Blood Loss After a Total Hip Replacement
• Interventions: Drug: Exacyl®; Other: Placebo of Exacyl®

• Registration Number: NCT02403596
• Lead Sponsor: University Hospital, Brest

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.

Study Timeline

• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-31
• Study Start: 2015-10-20
• Primary Completion: 2017-08-29
• Study Completion: 2017-08-29
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Exacyl®: Standard treatment	Exacyl®	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
Group 1: Exacyl®: Standard treatment	Placebo of Exacyl®	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
Group 2: Exacyl®: Extended treatment	Exacyl®	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
Group 3: Placebo	Placebo of Exacyl®	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

Primary Outcome Measures

Name	Time	Method
Total blood loss	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

Name	Time	Method
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

Trial Locations

Locations (4)

Polyclinique de Keraudren; 🇫🇷 Brest, France

CHRU Brest; 🇫🇷 Brest, France

HIA Clermont Tonnerre Brest; 🇫🇷 Brest, France

CH Morlaix; 🇫🇷 Morlaix, France