Blood Loss After a Total Hip Replacement Clinical Trial
— ESPEROfficial title:
Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV
| Verified date | January 2018 |
| Source | University Hospital, Brest |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 231 |
| Est. completion date | August 29, 2017 |
| Est. primary completion date | August 29, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU Brest | Brest | |
| France | HIA Clermont Tonnerre Brest | Brest | |
| France | Polyclinique de Keraudren | Brest | |
| France | CH Morlaix | Morlaix |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Brest | Bayer |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Difference in haemoglobin level (g/dL) between Day-1 and Day+3 | 5 days | ||
| Secondary | Maximum difference in haemoglobin level (g/dL) from D-1 up to D+3 | 5 days | ||
| Secondary | Number of transfusions and volume in mL performed during hospitalisation (operating theatre and unit) | 5 days | ||
| Secondary | Major haemorrhagic events, clinically significant non-major haemorrhagic events and minor haemorrhagic events | 3 month | ||
| Secondary | Surgical revision | 3 month | ||
| Secondary | Occurrence of venous or arterial thromboembolic events | 3 month | ||
| Secondary | Local infectious complications | 3 month | ||
| Secondary | Death due to any cause and death due to cardiovascular cause | 3 month |