Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Surgery Reduce Postoperative Haemarthrosis

Does Oral Administration of Tranexamic Acid in Anterior Cruciate Ligament Arthroscopic Surgery Reduce Postoperative Haemarthrosis and Improve Functional Prognosis?

To find superiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss, haemarthrosis prevalence and improvement functional prognosis in anterior cruciate ligament arthroscopy.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Rupture; Arthroscopy; Hemorrhage Postoperative; Total Blood Loss
• Intervention / Treatment: Drug: Oral tablet; Drug: Placebo

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 (Anticipated): 104
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nicolas Piette, MD; Phone Number: 003242843824; Email: piettenicolas@me.com

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • CHU de Liège
    • Contact: Michele Carella, MD; Phone Number: 003242843658

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary arthroscopic surgery for anterior cruciate ligament reconstruction

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; 52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy	Drug: Oral tablet; Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
Placebo Comparator: Placebo; 52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy	Drug: Placebo; Oral administration of lactose tablet (placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of haemarthrosis	Postoperative (drainage) blood loss	First 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain score on numeric ratio scale (NRS) from 0 (no pain) to 10 (worst pain)	24 hours after surgery
Postoperative pain	Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)	72 hours after surgery
Postoperative pain	Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)	7 days after surgery
Postoperative pain	Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)	15 days after surgery
Clinical evaluation of functional recovery	Tegner activity score from 0 (no activity) to 10 (competitive sport)	1 days after surgery
Clinical evaluation of functional recovery	Tegner activity score from 0 (no activity) to 10 (competitive sport)	3 days after surgery
Clinical evaluation of functional recovery	Tegner activity score from 0 (no activity) to 10 (competitive sport)	7 days after surgery
Clinical evaluation of functional recovery	Tegner activity score from 0 (no activity) to 10 (competitive sport)	15 days after surgery
Length of hospital stay	Total days of hospitalization	First 30 days 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.
• Muhunthan K, Balakumar S, Navaratnaraja TS, Premakrishna S, Arulkumaran S. Plasma Concentrations of Tranexamic Acid in Postpartum Women After Oral Administration. Obstet Gynecol. 2020 Apr;135(4):945-948. doi: 10.1097/AOG.0000000000003750.
• Karaaslan F, Karaoglu S, Yurdakul E. Reducing Intra-articular Hemarthrosis After Arthroscopic Anterior Cruciate Ligament Reconstruction by the Administration of Intravenous Tranexamic Acid: A Prospective, Randomized Controlled Trial. Am J Sports Med. 2015 Nov;43(11):2720-6. doi: 10.1177/0363546515599629. Epub 2015 Sep 2.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Hemorrhage; Rupture; Postoperative Hemorrhage; Hemarthrosis; Exsanguination
• Other Study ID Numbers: TRANEX-LCA

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