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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
HIA Clermont Tonnerre Brest
Brest, France
Polyclinique de Keraudren
Brest, France
CHRU Brest
Brest, France
CH Morlaix
Morlaix, France
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
Time frame: Between Day-1of surgery and Day+3 of surgery (5 days)
Difference in haemoglobin level (g/dL) between Day-1 and Day+3
Time frame: 5 days
Maximum difference in haemoglobin level (g/dL) from D-1 up to D+3
Time frame: 5 days
Number of transfusions and volume in mL performed during hospitalisation (operating theatre and unit)
Time frame: 5 days
Major haemorrhagic events, clinically significant non-major haemorrhagic events and minor haemorrhagic events
Time frame: 3 month
Surgical revision
Time frame: 3 month
Occurrence of venous or arterial thromboembolic events
Time frame: 3 month
Local infectious complications
Time frame: 3 month
Death due to any cause and death due to cardiovascular cause
Time frame: 3 month
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