Study the Anti-inflammatory Effect of Tranexamic Acid When Used in Anterior Cruciate Ligament Reconstruction.

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChirec

About this trial

Tranexamic acid (TXA) is widely used in orthopedic surgery to reduce perioperative blood loss, particularly in total hip and knee arthroplasty, due to its antifibrinolytic mechanism, low cost, broad availability, and established safety profile. Its use has recently expanded to minimally invasive procedures such as knee arthroscopy and ACL reconstruction, where postoperative hemarthrosis-rather than intraoperative bleeding-is a major cause of pain, swelling, reduced range of motion, delayed rehabilitation, and impaired early recovery.

Randomized trials and meta-analyses in arthroscopic ACL reconstruction show that TXA, administered intravenously, intra-articularly, or both, reduces postoperative hemarthrosis, joint swelling, drainage volume, and early pain, while improving early functional outcomes. These benefits are mainly short term, with no consistent long-term differences, and no increased risk of thromboembolic events. Evidence in arthroscopic meniscectomy is more limited but suggests modest improvements in early recovery, which may still be clinically meaningful given TXA's favorable risk-benefit profile.

Beyond its antifibrinolytic effects, TXA may influence inflammatory pathways by inhibiting plasmin, which is involved in complement activation and inflammatory modulation. However, existing data are conflicting, with reports of both anti- and pro-inflammatory effects depending on surgical context and dosing. Importantly, most arthroscopy studies focus on clinical outcomes rather than systemic inflammation. To date, no study has comprehensively evaluated perioperative inflammatory responses to TXA in arthroscopic knee surgery, making this low-trauma setting an ideal model to investigate its potential inflammatory effects.

Eligibility criteria

Qualifiers

Adults aged 18 years or older.

Male or female patients scheduled for primary anterior cruciate ligament (ACL) reconstruction.

Surgery performed under spinal anesthesia, combined with a postoperative adductor canal block for analgesia.

American Society of Anesthesiologists (ASA) physical status I or II.

Disqualifiers

Age under 18 years.

Pregnancy or breastfeeding.

Preoperative treatment with anticoagulant or antiplatelet therapy that cannot be safely discontinued.

Known coagulation disorders or history of abnormal bleeding.

Trial design

Treatments tested in this trial

  • Tranexamic Acid (TXA)
  • Placebo (NaCl 0,9%)

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Chirec

Lead sponsor

Centre Hospitalier Universitaire Brugmann

Collaborator

Erasme University Hospital

Collaborator