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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV

Conditions
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Blood Loss After a Total Hip Replacement

Intervention / Treatment
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* Drug: Exacyl®
* Other: Placebo of Exacyl®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Exacyl®: Standard treatment<br>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®<br> <br> * Other names: Tranexamic acid;Other: Placebo of Exacyl®<br> <br> |
| Experimental: Group 2: Exacyl®: Extended treatment<br>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®<br> <br> * Other names: Tranexamic acid;|
| Placebo Comparator: Group 3: Placebo<br>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®<br> <br> |

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exacyl, Hip replacement, rivaroxaban, blood loss