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

University of Liege

Status and phase: Unknown; Phase 4

Conditions: Arthroscopy; Total Blood Loss; Hemorrhage Postoperative; Anterior Cruciate Ligament Rupture

Treatments: Drug: Oral tablet; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04855877

TRANEX-LCA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

Oral Tranexamic Acid

Active Comparator group

Description:

52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

Treatment:

Drug: Oral tablet

Placebo

Placebo Comparator group

Description:

52 patients scheduled for primary anteriori cruciate ligament surgery by arthroscopy

Treatment:

Drug: Placebo