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

NCT07332910 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: Chirec
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemarthrosis; ACL Reconstruction

Outcome Measures

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.

  24 hours

Secondary Outcomes (7)

• Hidden blood loss

  3 days

• Anti-inflammatory response

  24 hours

• Fibrinolysis

  24 hours

• Rehabilitation score

  1 week

• Rehabilitation score

  1 week

Study Arms (2)

Tranexamin acid

ACTIVE COMPARATOR

This group will receive 1 dose of tranexamic acid during the induction phase, before the surgical tourniquet

Drug: Tranexamic Acid (TXA)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (NaCl 0,9%)

Interventions

Placebo (NaCl 0,9%) DRUG

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

Also known as: Placebo

Placebo

Tranexamic Acid (TXA) DRUG

1 dose of Tranexamic Acid 15 mg/kg

Also known as: TXA

Tranexamin acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Procedure performed by a single, standardized surgical team.
• Ability to provide written informed consent.

You may not qualify if:

• 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.
• Known hypersensitivity or allergy to tranexamic acid.
• History of seizure disorders or epilepsy.

Sponsors & Collaborators

• Chirec: lead
• Centre Hospitalier Universitaire Brugmann: collaborator
• Erasme University Hospital: collaborator

Study Sites (1)

Chirec Delta

Brussels, 1160, Belgium

Location

Related Publications (16)

• Prudovsky I, Kacer D, Zucco VV, Palmeri M, Falank C, Kramer R, Carter D, Rappold J. Tranexamic acid: Beyond antifibrinolysis. Transfusion. 2022 Aug;62 Suppl 1:S301-S312. doi: 10.1111/trf.16976. Epub 2022 Jul 14.

  PMID: 35834488 BACKGROUND

• Alkhatib N, AlNouri M, Abdullah ASA, Ahmad Alzobi OZ, Alkaramany E, Sasaki E, Ishibashi Y. Tranexamic Acid Use in Anterior Cruciate Ligament Reconstruction Decreases Bleeding Complications: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Arthroscopy. 2022 Feb;38(2):506-518.e6. doi: 10.1016/j.arthro.2021.07.030. Epub 2021 Aug 4.

  PMID: 34358640 BACKGROUND

• Grant AL, Letson HL, Morris JL, McEwen P, Hazratwala K, Wilkinson M, Dobson GP. Tranexamic acid is associated with selective increase in inflammatory markers following total knee arthroplasty (TKA): a pilot study. J Orthop Surg Res. 2018 Jun 18;13(1):149. doi: 10.1186/s13018-018-0855-5.

  PMID: 29914535 BACKGROUND

• Johns WL, Walley KC, Hammoud S, Gonzalez TA, Ciccotti MG, Patel NK. Tranexamic Acid in Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2021 Dec;49(14):4030-4041. doi: 10.1177/0363546521988943. Epub 2021 Feb 25.

  PMID: 33630652 BACKGROUND

• Fried JW, Bloom DA, Hurley ET, Baron SL, Popovic J, Campbell KA, Strauss EJ, Jazrawi LM, Alaia MJ. Tranexamic Acid Has No Effect on Postoperative Hemarthrosis or Pain Control After Anterior Cruciate Ligament Reconstruction Using Bone-Patellar Tendon-Bone Autograft: A Double-Blind, Randomized, Controlled Trial. Arthroscopy. 2021 Jun;37(6):1883-1889. doi: 10.1016/j.arthro.2021.01.037. Epub 2021 Jan 30.

  PMID: 33529783 BACKGROUND

• Hetsroni I. Tranexamic Acid During Anterior Cruciate Ligament Reconstruction Reduced Drained Blood Volume on Day 1 and Hemarthrosis Up to Day 15 but Did Not Improve Clinical Outcomes at 3 Months. J Bone Joint Surg Am. 2019 Aug 21;101(16):1516. doi: 10.2106/JBJS.19.00514. No abstract available.

  PMID: 31436663 BACKGROUND

• Goldstein K, Jones C, Kay J, Shin J, de Sa D. Tranexamic Acid Administration in Arthroscopic Surgery Is a Safe Adjunct to Decrease Postoperative Pain and Swelling: A Systematic Review and Meta-analysis. Arthroscopy. 2022 Apr;38(4):1366-1377.e9. doi: 10.1016/j.arthro.2021.10.001. Epub 2021 Oct 14.

  PMID: 34655767 BACKGROUND

• Mousavi H, Akbari-Aghdam H, Entezari R. The effect of tranexamic acid injection during anterior cruciate ligament reconstruction surgery on postoperative bleeding, pain and swelling. Eur J Orthop Surg Traumatol. 2023 Apr;33(3):639-644. doi: 10.1007/s00590-022-03318-8. Epub 2022 Jul 2.

  PMID: 35779145 BACKGROUND

• Ma R, Wu M, Li Y, Wang J, Wang W, Yang P, Wang K. The comparative efficacies of intravenous administration and intra-articular injection of tranexamic acid during anterior cruciate ligament reconstruction for reducing postoperative hemarthrosis: a prospective randomized study. BMC Musculoskelet Disord. 2021 Jan 26;22(1):114. doi: 10.1186/s12891-021-03990-7.

  PMID: 33499848 BACKGROUND

• Felli L, Revello S, Burastero G, Gatto P, Carletti A, Formica M, Alessio-Mazzola M. Single Intravenous Administration of Tranexamic Acid in Anterior Cruciate Ligament Reconstruction to Reduce Postoperative Hemarthrosis and Increase Functional Outcomes in the Early Phase of Postoperative Rehabilitation: A Randomized Controlled Trial. Arthroscopy. 2019 Jan;35(1):149-157. doi: 10.1016/j.arthro.2018.07.050.

  PMID: 30611343 BACKGROUND

• Cen L, Liu H, Li M, Zhang YF, Zhang HJ, Huang ZY. Intraoperative tranexamic acid reduces postoperative haemarthrosis and improves early functional outcomes in double-bundle anterior cruciate ligament reconstruction. J Orthop. 2024 Dec 10;65:51-56. doi: 10.1016/j.jor.2024.12.005. eCollection 2025 Jul.

  PMID: 39801905 BACKGROUND

• Tan TK, Ng KT, Lim HJ, Radic R. Effect of tranexamic acid in arthroscopic anterior cruciate ligament repair: A systematic review and meta-analysis of randomised clinical trials. J Orthop Surg (Hong Kong). 2021 May-Aug;29(2):23094990211017352. doi: 10.1177/23094990211017352.

  PMID: 34027721 BACKGROUND

• Alaia MJ, Gipsman AM. Editorial Commentary: The Benefits of Tranexamic Acid May Outweigh Risks in Arthroscopy and Sports Medicine. Arthroscopy. 2021 Apr;37(4):1334-1336. doi: 10.1016/j.arthro.2021.01.027.

  PMID: 33812531 BACKGROUND

• Nugent M, May JH, Parker JD, Kieser DC, Douglas M, Pereira R, Lim KS, Hooper GJ. Does Tranexamic Acid Reduce Knee Swelling and Improve Early Function Following Arthroscopic Meniscectomy? A Double-Blind Randomized Controlled Trial. Orthop J Sports Med. 2019 Aug 29;7(8):2325967119866122. doi: 10.1177/2325967119866122. eCollection 2019 Aug.

  PMID: 31497612 BACKGROUND

• Na Y, Jia Y, Shi Y, Liu W, Han C, Hua Y. Administration of Tranexamic Acid to Reduce Intra-articular Hemarthrosis in ACL Reconstruction: A Systematic Review. Orthop J Sports Med. 2022 Jan 28;10(1):23259671211061726. doi: 10.1177/23259671211061726. eCollection 2022 Jan.

  PMID: 35111862 BACKGROUND

• Lei Y, Xie J, Huang Q, Huang W, Pei F. Additional benefits of multiple-dose tranexamic acid to anti-fibrinolysis and anti-inflammation in total knee arthroplasty: a randomized controlled trial. Arch Orthop Trauma Surg. 2020 Aug;140(8):1087-1095. doi: 10.1007/s00402-020-03442-2. Epub 2020 Apr 6.

  PMID: 32253548 BACKGROUND

MeSH Terms

Conditions

Hemarthrosis

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Karim Touihri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Céline El Haddad, Anesthesia

CONTACT

+32 475466655; celineelha@outlook.fr

Touihri Clanet, Anesthesia

CONTACT

matthieuclanet@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Group 1: 1 dose of tranexamic acid (15mg/kg) during induction Group 2: No tranexamic acid

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 12, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

BE (1)