NCT02252497

Tranexamic Acid in Total Hip Arthroplasty.

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hip Arthroplasty

Interventions

Type	Name	Description
DRUG	Active comparator : Tranexamic Acid (Exacyl)	* 1g Exacyl Intra Venous, just before surgery * Then infusion of 1g of Exacyl over eight hours .
DRUG	Placebo comparator : physiologic serum	* 1g Intra Venous just before surgery * Then infusion of 1g of physiologic serum over eight hours

Timeline

• Start date: 2014-04-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2014-09-30
• Last updated: 2016-03-14

Locations

1 site across 1 country: France