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

Phase 4

• Conditions: Anterior Cruciate Ligament Rupture; Hemorrhage Postoperative; Total Blood Loss; Arthroscopy
• Interventions: Drug: Oral tablet; Drug: Placebo

• Registration Number: NCT04855877
• Lead Sponsor: University of Liege

Brief Summary

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.

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: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-22
• Status Verified: 2021-07
• Study Start: 2021-07-06
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Tranexamic Acid	Oral tablet	52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy
Placebo	Placebo	52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

Primary Outcome Measures

Name	Time	Method
Assessment of haemarthrosis	First 24 hours after surgery	Postoperative (drainage) blood loss

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	15 days after surgery	Postoperative pain score on numeric rating scale (NRS) from 0 (no pain) to 10 (worst pain)
Clinical evaluation of functional recovery	15 days after surgery	Tegner activity score from 0 (no activity) to 10 (competitive sport)
Length of hospital stay	First 30 days after surgery	Total days of hospitalization

Trial Locations

Locations (1)

CHU de Liège; 🇧🇪 Liège, Belgium