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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004552-37 | EudraCT Number | ||
| 2022-502532-38-01 | Other Identifier | CTIS |
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A single preoperative dose of tranexamic acid (TXA) reduces blood loss and red blood cell transfusion in primary hip arthroplasty. Numerous regimens have been tested, ranging from 10mg/kg up to 3g. However the optimal dose to administer is unknown.
This dose-response study is a randomized double blind study with five groups of 30 patients each. Patients will be randomized to placebo, tranexamic acid (TXA) 300 mg, tranexamic acid (TXA) 500 mg, tranexamic acid (TXA) 1000 mg or tranexamic acid (TXA) 3000 mg. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of tranexamic acid (TXA) plasma concentration as a predictor of intra and postoperative D-Dimer values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patient will be included in this group by randomization and they will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision. |
|
| Group 1: perfusion of 300 mg Exacyl | Experimental | Patient will be included in the group 2 by randomization and they will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. |
|
| Group 2: perfusion of 500 mg Exacyl | Experimental | Patient will be included in the group 2 by randomization and they will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision.. |
|
| Group 3: perfusion of 1000 mg Exacyl | Experimental | Patient will be included in the group 3 by randomization and they will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. |
|
| Group 4: perfusion of 3000 mg Exacyl |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Patient will receive an intravenous perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 9 minutes, starting at the time of surgical incision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| haemoglobin decrease in the perioperative period | Percentage of haemoglobin change in the perioperative period. It requires the sampling of haemoglobin just before surgery (Day 1) and on the fourth postoperative day | Day 1 to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Tranexamic acid pharmacokinetics | For tranexamic acid pharmacokinetics, the outcome measure is the sampling of tranexamic blood concentration. | Day 1 |
| D-Dimer kinetics | For tranexamic acid pharmacodynamics, the outcome is the sampling of D-Dimer levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julien LANOISELEE, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Etienne | Saint-Etienne | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41338640 | Derived | Zufferey PJ, Barrat E, Deygas B, Lanoiselee J, Ollier E. Dose-effect relationship of intravenous tranexamic acid on perioperative haemoglobin drop in total hip arthroplasty (PRADO study): study protocol for a randomised, double-blind, placebo-controlled, dose-response study. BMJ Open. 2025 Dec 3;15(12):e100265. doi: 10.1136/bmjopen-2025-100265. |
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randomized double blind study
Patient will be included in the group 4 by randomization and they will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. |
|
| Group 1: perfusion of 300 mg Exacyl | Drug | Patient will receive an intravenous perfusion of 300 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. |
|
| Group 2: perfusion of 500 mg Exacyl | Drug | Patient will receive an intravenous perfusion of 500 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. |
|
| Group 3: perfusion of 1000 mg Exacyl | Drug | Patient will receive an intravenous perfusion of 1000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. |
|
| Group 4: perfusion of 3000 mg Exacyl | Drug | Patient will receive an intravenous perfusion of 3000 mg Exacyl (tranexamic acid) intravenous (IV) over 9 minutes, starting at the time of surgical incision. |
|
| Day 1 |
| allogenic red blood cell transfusion | For allogenic red blood cell transfusion, the outcome measure will be the percentage of patients that will receive the transfusion of at least one allogenic red blood cell unit in the perioperative period. | Day 1 to day 8 |
| severe anaemia | For severe anaemia (defined as a level of haemoglobin <10 gram by deciliter), the outcome measure will be the percentage of patients that will have at least one value of haemoglobin <10 gram by deciliter in the perioperative period. | Day 1 to day 8 |
| incidence of symptomatic thrombotic events and death | For the incidence of symptomatic thrombotic events and death, the outcome measure is a combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death. | Day 1 to day 8 |
| occurrence of a seizure | The endpoint is a combined criteria endpoint involving either the clinical observation of a generalized tonic-clonic seizure or a partial seizure or an epilepsy confirmed by an electroencephalogram interpreted by a neurologist blinded to the patient's inclusion group. | Day 8 |
| number of adverse events | collection in medical records the adverse events at 45 days after surgery :
| Day: 45 |
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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