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

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.

Study Overview

• Status: Completed
• Conditions: Arthroplasty Complications; Hemorrhage Postoperative; Total Blood Loss
• Intervention / Treatment: Drug: Tranexamic Acid Oral Product; Drug: Tranexamic acid injection

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 Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU de Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Tranexamic Acid; 128 patients scheduled for primary total hip arthroplasty	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
Active Comparator: Intravenous Tranexamic Acid; 128 patients scheduled for primary total hip arthroplasty	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total blood loss	Peroperative (suction) and postoperative (drainage) total blood loss	First 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentration of tranexamic acid	Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group	2 hours after oral administration
Serum concentration of tranexamic acid	Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group	6 hours after oral administration
Serum concentration of tranexamic acid	Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group	30 minutes after intravenous administration
Serum concentration of tranexamic acid	Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group	4 hours after intravenous administration
Serum hemoglobin variation	Variation of serum hemoglobin between preoperative and postoperative period	24 hours after surgery
Serum hemoglobin variation	Variation of serum hemoglobin between preoperative and postoperative period	72 hours after surgery
Incidence of blood transfusion	Incidence of blood transfusion in two groups	72 hours after surgery
Incidence of thromboembolic complications	Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis	72 hours after surgery
Length of hospitalisation stay	Difference between two groups of total hospitalisation days	1 week after surgery

Collaborators and Investigators

• Sponsor: University of Liege

Publications and helpful links

General Publications

• Fillingham YA, Ramkumar DB, Jevsevar DS, Yates AJ, Bini SA, Clarke HD, Schemitsch E, Johnson RL, Memtsoudis SG, Sayeed SA, Sah AP, Della Valle CJ. Tranexamic acid in total joint arthroplasty: the endorsed clinical practice guides of the American Association of Hip and Knee Surgeons, American Society of Regional Anesthesia and Pain Medicine, American Academy of Orthopaedic Surgeons, Hip Society, and Knee Society. Reg Anesth Pain Med. 2019 Jan;44(1):7-11. doi: 10.1136/rapm-2018-000024. No abstract available.
• Wu Y, Zeng Y, Hu Q, Li M, Bao X, Zhong J, Shen B. Blood loss and cost-effectiveness of oral vs intravenous tranexamic acid in primary total hip arthroplasty: A randomized clinical trial. Thromb Res. 2018 Nov;171:143-148. doi: 10.1016/j.thromres.2018.10.006. Epub 2018 Oct 6.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 14, 2022
• Study Completion (Actual): December 14, 2022

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hemorrhage; Postoperative Hemorrhage; Exsanguination; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2020-316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No