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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Tranexamic Acid (TXA)
Drug1 dose of Tranexamic Acid 15 mg/kg
Placebo (NaCl 0,9%)
DrugThis arm will receive NaCl 0,9% at the same volume as calculated for 15mg/kg of tranexamic acid
Treatment groups
Trial outcomes
Primary outcomes
Anti-inflammatory response: Variation of IL-6 over 24 hours
To evaluate the effect of a single intravenous dose of tranexamic acid on the perioperative inflammatory response, assessed by serial plasma interleukin-6 (IL-6) concentrations measured preoperatively, at 6 hours, and at 24 hours postoperatively, with quantification of the inflammatory burden using the area under the curve (AUC) over the first 24 postoperative hours.
Secondary outcomes
Hidden blood loss
To quantify hidden blood loss (HBL) using perioperative hemoglobin and hematocrit measurements obtained preoperatively, at 24 hours, and on postoperative day 3. Total blood loss (TBL) will be estimated using validated hematocrit-based formulas incorporating postoperative day-3 hematocrit and estimated blood volume, and hidden blood loss will be calculated as HBL = TBL - intraoperative blood loss (IBL).
Anti-inflammatory response
To characterize the perioperative inflammatory profile associated with tranexamic acid administration by measuring plasma levels of TNF-α, IL-8, IFN-γ, IL-1α, IL-1β, IL-2, IL-4, IL-10, and C-reactive protein (CRP)at baseline, 6 hours, and 24 hours postoperatively.
Fibrinolysis
To assess the effect of tranexamic acid on perioperative fibrinolysis, evaluated through serial measurements of D-dimer levels obtained preoperatively, at 6 hours, and at 24 hours postoperatively.
Rehabilitation score
\- KOOS score: Knee Injury and Osteoarthritis Outcome Score - 0 (worse score) - 100 (best score).
Sponsors and contacts
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Chirec
Lead sponsor
Centre Hospitalier Universitaire Brugmann
Collaborator
Erasme University Hospital
Collaborator
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