Noninferiority Oral Tranexamic Acid vs Intravenous Administration in Total Hip Arthroplasty

• Sponsor: University of Liege (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04691362
• Collaborator: (none)
• Enrollment: 256
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 32
• Patients Per Site Per Month: 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhage Postoperative; Total Blood Loss; Arthroplasty Complications	Drug: Tranexamic Acid Oral Product; Drug: Tranexamic acid injection	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 256 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Double blinded randomized controlled trial. Patient, anesthesiologist and surgeon are blinded.
• Primary Purpose: Supportive Care
• Official Title: Study of the Noninferiority of an Oral vs Intravenous Administration of Tranexamic Acid in Total Hip Arthroplasty
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Total blood loss [First 48 hours after surgery]

   Peroperative (suction) and postoperative (drainage) total blood loss

Secondary Outcome Measures

1. Serum concentration of tranexamic acid [2 hours after oral administration]

   Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group

2. Serum concentration of tranexamic acid [6 hours after oral administration]

   Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group

3. Serum concentration of tranexamic acid [30 minutes after intravenous administration]

   Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group

4. Serum concentration of tranexamic acid [4 hours after intravenous administration]

   Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group

5. Serum hemoglobin variation [24 hours after surgery]

   Variation of serum hemoglobin between preoperative and postoperative period

6. Serum hemoglobin variation [72 hours after surgery]

   Variation of serum hemoglobin between preoperative and postoperative period

7. Incidence of blood transfusion [72 hours after surgery]

   Incidence of blood transfusion in two groups

8. Incidence of thromboembolic complications [72 hours after surgery]

   Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis

9. Length of hospitalisation stay [1 week after surgery]

   Difference between two groups of total hospitalisation days

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Liège	Liège		Belgium	4000

Sponsors and Collaborators

• University of Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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. Review.
• 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.

• Responsible Party: Jean François Brichant, Head of Anesthesiology Departement, University of Liege
• ClinicalTrials.gov Identifier: NCT04691362
• Other Study ID Numbers: 2020-316
• First Posted: Dec 31, 2020
• Last Update Posted: Jan 15, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemorrhage; Exsanguination; Postoperative Hemorrhage; Tranexamic Acid

Study Results

No Results Posted as of Jan 15, 2021