Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

Phase 4

Completed

• Conditions: Hemorrhage Postoperative; Total Blood Loss; Arthroplasty Complications
• Interventions: Drug: Tranexamic Acid Oral Product; Drug: Tranexamic acid injection

• Registration Number: NCT04691362
• Lead Sponsor: University of Liege

Brief 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.

Study Timeline

• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Study Start: 2021-01-01
• Status Verified: 2022-12
• Primary Completion: 2022-12-14
• Study Completion: 2022-12-14
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty

Exclusion Criteria

• Renal failure with serum creatinine level higher than 1,40 mg/dL
• Thromboembolic events in last 12 months before surgery
• Pregnancy
• Congenital or acquired coagulation diseases
• History of gastric surgery that could lead to malabsorption
• Diabetic gastro-paresis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Tranexamic Acid	Tranexamic Acid Oral Product	128 patients scheduled for primary total hip arthroplasty
Intravenous Tranexamic Acid	Tranexamic acid injection	128 patients scheduled for primary total hip arthroplasty

Primary Outcome Measures

Name	Time	Method
Total blood loss	First 48 hours after surgery	Peroperative (suction) and postoperative (drainage) total blood loss

Secondary Outcome Measures

Name	Time	Method
Incidence of thromboembolic complications	72 hours after surgery	Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis
Serum concentration of tranexamic acid	4 hours after intravenous administration	Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Incidence of blood transfusion	72 hours after surgery	Incidence of blood transfusion in two groups
Length of hospitalisation stay	1 week after surgery	Difference between two groups of total hospitalisation days
Serum hemoglobin variation	72 hours after surgery	Variation of serum hemoglobin between preoperative and postoperative period

Trial Locations

Locations (1)

CHU de Liège; 🇧🇪 Liège, Belgium