NCT07332910: TXA

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

Not yet recruiting Phase 4 Last updated 12 January 2026

What this trial tests

Phase 4 trial testing Tranexamic Acid (TXA) in ACL Reconstruction in 60 participants. Not yet recruiting.

Timeline

20 January 2026

Primary endpoint
1 June 2026

1 June 2026

Quick facts

Lead sponsor	Chirec
Phase	Phase 4
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	60
Start date	20 January 2026
Primary completion	1 June 2026
Estimated completion	1 June 2026
Sites	1 location across Belgium

Drugs / interventions tested

• Tranexamic Acid (TXA) — full drug profile →
• Placebo (NaCl 0,9%)

Conditions studied

• ACL Reconstruction — all drugs for ACL Reconstruction →
• Hemarthrosis — all drugs for Hemarthrosis →

Sponsor

Chirec

Who can join

18 and older, any sex, with ACL Reconstruction or Hemarthrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.