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| ID | Type | Description | Link |
|---|---|---|---|
| RB15.005 | Other Identifier | Brest UH |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Exacyl®: Standard treatment | Experimental | 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 | Experimental | 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 Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exacyl® | Drug |
|
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Rapidly destructive arthrosis of the hip
History of prior surgery on the operative hip
Contraindications to the use of tranexamic acid:
Contraindications to the use of rivaroxaban
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIA Clermont Tonnerre Brest | Brest | 29200 | France | |||
| Polyclinique de Keraudren |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo of Exacyl® | Other |
|
| 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 |
| Brest |
| 29287 |
| France |
| CHRU Brest | Brest | 29609 | France |
| CH Morlaix | Morlaix | 29672 | France |