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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000791-15 | EudraCT Number |
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The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over height hours on blood loss.
The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over eight hours on blood loss. The efficacy of TXA on blood loss is greatly influenced by the timing of its administration relative to surgery. In total hip arthroplasty, TXA should be started before surgery. However the optimal duration of TXA administration in hip arthroplasty is unknown. Numerous studies have shown that a single preoperative administration of TXA is effective. Yet indirect comparisons indicate a higher efficacy of TXA started before surgery and followed with a continuous infusion or repeated boluses. Our hypothesis is that a single preoperative administration of TXA is not sufficient to maintain therapeutic concentrations of TXA in the postoperative period. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of TXA plasma concentration as a predictor of blood loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Active Comparator |
|
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| Physiologic serum | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active comparator : Tranexamic Acid (Exacyl) | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Calculated volume of blood losses in the peroperative period. | It requires the sampling of haemoglobin at the beginning of surgery and in the fifth day. | between the beginning of surgery and the fifth day |
| Measure | Description | Time Frame |
|---|---|---|
| the patients' percentage that will receive the transfusion of at least one allogenic globular sediment | the patients' percentage that will receive the transfusion of at least one allogenic globular sediment in the peroperative period. | between D1 (day of surgery) and D5 (the fourth postoperative day) |
| incidence of symptomatic thrombotic events and death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul ZUFFEREY, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
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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 comparator : physiologic serum | Drug |
|
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combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death |
| in 6 weeks |
| tranexamic acid pharmacokinetic analyses | non linear mixt effect model | from the beginning of surgery up to 8 hours |