Tranexamic Acid in Total Hip Arthroplasty.

Centre Hospitalier Universitaire de Saint Etienne168 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

168

Conditions

Hip Arthroplasty

Interventions

Active comparator : Tranexamic Acid (Exacyl)DRUG

* 1g Exacyl Intra Venous, just before surgery * Then infusion of 1g of Exacyl over eight hours .

Placebo comparator : physiologic serumDRUG

* 1g Intra Venous just before surgery * Then infusion of 1g of physiologic serum over eight hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

CHU de Saint-Etienne

Saint-Etienne, France

Outcomes

Primary Outcomes

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.

Time frame: between the beginning of surgery and the fifth day

Secondary Outcomes

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.

Time frame: 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

Time frame: in 6 weeks

tranexamic acid pharmacokinetic analyses

non linear mixt effect model

Time frame: from the beginning of surgery up to 8 hours

Data from ClinicalTrials.gov

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