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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tranexamic Acid (TXA)

    Drug

    1 dose of Tranexamic Acid 15 mg/kg

  • Placebo (NaCl 0,9%)

    Drug

    This arm will receive NaCl 0,9% at the same volume as calculated for 15mg/kg of tranexamic acid

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Tranexamin acidActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 hours

Secondary outcomes

1

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).

Time frame
3 days
2

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.

Time frame
24 hours
3

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.

Time frame
24 hours
4

Rehabilitation score

\- KOOS score: Knee Injury and Osteoarthritis Outcome Score - 0 (worse score) - 100 (best score).

Time frame
1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chirec

Lead sponsor

Centre Hospitalier Universitaire Brugmann

Collaborator

Erasme University Hospital

Collaborator

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