Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

Arthroplasty Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691362
• Other study ID #: 2020-316
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: December 14, 2022

Study information

• Verified date: December 2022
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty Complications
• Hemorrhage
• Hemorrhage Postoperative
• Postoperative Hemorrhage
• Total Blood Loss

Intervention

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
• 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

Locations

Country	Name	City	State
Belgium	CHU de Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total blood loss	Peroperative (suction) and postoperative (drainage) total blood loss	First 48 hours after surgery
Secondary	Serum concentration of tranexamic acid	Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group	2 hours after oral administration
Secondary	Serum concentration of tranexamic acid	Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group	6 hours after oral administration
Secondary	Serum concentration of tranexamic acid	Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group	30 minutes after intravenous administration
Secondary	Serum concentration of tranexamic acid	Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group	4 hours after intravenous administration
Secondary	Serum hemoglobin variation	Variation of serum hemoglobin between preoperative and postoperative period	24 hours after surgery
Secondary	Serum hemoglobin variation	Variation of serum hemoglobin between preoperative and postoperative period	72 hours after surgery
Secondary	Incidence of blood transfusion	Incidence of blood transfusion in two groups	72 hours after surgery
Secondary	Incidence of thromboembolic complications	Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis	72 hours after surgery
Secondary	Length of hospitalisation stay	Difference between two groups of total hospitalisation days	1 week after surgery