Tranexamic Acid in Total Hip Arthroplasty.

Phase 4

Completed

• Conditions: Hip Arthroplasty

• Registration Number: NCT02252497
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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

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 Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-09-26
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-09-30
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Calculated volume of blood losses in the peroperative period.	between the beginning of surgery and the fifth day	It requires the sampling of haemoglobin at the beginning of surgery and in the fifth day.

Secondary Outcome Measures

Name	Time	Method
tranexamic acid pharmacokinetic analyses	from the beginning of surgery up to 8 hours	non linear mixt effect model
the patients' percentage that will receive the transfusion of at least one allogenic globular sediment	between D1 (day of surgery) and D5 (the fourth postoperative day)	the patients' percentage that will receive the transfusion of at least one allogenic globular sediment in the peroperative period.
incidence of symptomatic thrombotic events and death	in 6 weeks	combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 SAINT-ETIENNE cedex 2, France