Blood Loss After a Total Hip Replacement
Conditions
Keywords
Hip replacement, rivaroxaban, exacyl, blood loss
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.
Interventions
DRUGExacyl®
OTHERPlacebo of Exacyl®
Sponsors
Bayer
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Difference in haemoglobin level (g/dL) between Day-1 and Day+3 | 5 days |
| 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 |
| Surgical revision | 3 month |
Countries
France
Outcome results
None listed