NCT04691362

Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

Study of the Noninferiority of an Oral vs Intravenous Administration of Tranexamic Acid in Total Hip Arthroplasty

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: University of Liege · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.

Detailed description

Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.

Conditions

• Hemorrhage Postoperative
• Total Blood Loss
• Arthroplasty Complications

Interventions

Type	Name	Description
DRUG	Tranexamic Acid Oral Product	Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
DRUG	Tranexamic acid injection	Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-14
• Completion: 2022-12-14
• First posted: 2020-12-31
• Last updated: 2022-12-15

Locations

1 site across 1 country: Belgium