Tranexamic Acid in Total Hip Arthroplasty.

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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.

Official Title
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Tranexamic Acid in Total Hip Arthroplasty: Single Preoperative Administration vs Perioperative Administration. A Randomized Control Trial.

Conditions
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Hip Arthroplasty

Intervention / Treatment
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* Drug: Active comparator : Tranexamic Acid (Exacyl)
* Drug: Placebo comparator : physiologic serum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient requiring hip arthroplasty in first line, except recent hip fracture (less than 3 months) Consent of the patient or a family member or the support person. Exclusion Criteria: Contraindication to tranexamic acid. Contraindication to apixaban. Pregnancy. Patient receiving a curative anticoagulating treatment in the preoperative period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid<br>1g Intra Venous just before surgery Then infusion of 1g of Exacyl over eight hours. | Drug: Active comparator : Tranexamic Acid (Exacyl)<br>* 1g Exacyl Intra Venous, just before surgery Then infusion of 1g of Exacyl over eight hours .<br>|
| Placebo Comparator: Physiologic serum<br>1g Intra Venous, just before surgery Then infusion of 1g of physiologic serum over eight hours. | Drug: Placebo comparator : physiologic serum<br>* 1g Intra Venous just before surgery Then infusion of 1g of physiologic serum over eight hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip arthroplasty, Tranexamic acid, randomized control trial