A Study Aiming to Demonstrate That the Addition of Intravenous (IV) Tranexamic Acid-Compared to Placebo-During Anterior Cruciate Ligament (ACL) Reconstruction Results in Reduced Blood Loss and Postoperative Pain.

NCT07753161 | Completed DMC

• 1 other identifier: 2020-000039-33
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Various reconstruction and graft harvesting techniques are used for ACL reconstruction. The most common techniques involve harvesting one or more hamstring tendons. These tendons are harvested using minimally invasive approaches with "strippers," which do not allow for hemostasis at the base of the thigh-specifically at the myotendinous junction where the proximal end of the graft is severed. This lack of hemostasis consistently leads to varying degrees of bleeding in the hours or even days following surgery. This bleeding causes pain, hematomas, and muscle inhibition (particularly of the hamstrings), thereby hindering the resumption of activities and delaying physical therapy progress. Tranexamic acid is an antifibrinolytic agent currently gaining widespread use in orthopedic surgery to prevent intraoperative and postoperative bleeding, particularly in knee and hip arthroplasty. Numerous recent publications, including meta-analyses, have demonstrated its efficacy and safety. Only one study has investigated the effect of tranexamic acid in the context of ACL reconstruction, showing a reduction in postoperative pain. The main objective is to evaluate the effect of intravenous tranexamic acid on hemoglobin loss at postoperative day 2 in patients undergoing primary ACL reconstruction with hamstring tendon harvesting on an outpatient basis.

Conditions

Ligamentoplasty; Hemoglobin

Outcome Measures

Primary Outcomes (1)

• Hemoglobin loss

  Hemoglobin loss between Day 0 (pre-operative, before any intervention) and Day 2 (post-operative), expressed as an absolute difference.

  Day 0 (before intervention) and day 2 (post surgery)

Study Arms (2)

Patient treated with Tranexamin acid

EXPERIMENTAL

Procedure: ACL reconstruction

Patient treated with placebo

PLACEBO COMPARATOR

Procedure: ACL reconstruction

Interventions

ACL reconstruction PROCEDURE

The surgical procedure is performed under regional or general anesthesia. The study treatment is tranexamic acid. It is administered as two 50 ml slow intravenous (IV) infusions (via infusion bags) containing 1 gram each, resulting in a total injected dose of 2 grams. The first infusion is administered at H0-1h (before induction) and the second at H0+3h. The comparator treatment is a placebo (saline solution). It is administered as two 50 ml slow intravenous (IV) infusions (via infusion bags). The first infusion is administered at H0-1h (before induction) and the second at H0+3h.

Patient treated with Tranexamin acid; Patient treated with placebo

Eligibility Criteria

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

You may qualify if:

• Male or female patient aged over 18 years4
• Patient with a surgical indication for primary reconstruction of an isolated ACL, +/- requiring an anterolateral reconstruction procedure or meniscectomy/meniscal repair
• Planned outpatient surgical procedure
• Patient affiliated with or a beneficiary of a social security scheme
• Patient informed about the study and having signed the informed consent form

You may not qualify if:

• Patient with a history of ACL surgery
• Patient with a history of knee surgery other than meniscectomy
• Patient with multi-ligament knee injuries (PCL, MCL, or LCL)
• Patient with a contraindication to the use of tranexamic acid: Hypersensitivity to the active substance or any of the excipients, acute venous or arterial thrombosis, fibrinolytic states resulting from consumptive coagulopathy (except in states associated with predominant activation of the fibrinolytic system with acute severe hemorrhage), severe renal impairment (risk of accumulation), history of convulsions, intrathecal and intraventricular injections, intracerebral applications (risk of cerebral edema and convulsions)
• Patient with a hemostatic disorder, undergoing treatment with VKAs or anticoagulants, or receiving hormone replacement therapy
• Patient with hepatic impairment
• Patient with renal impairment
• Patient unable or not in a position to agree to the entire procedure and follow-up required by the study
• Patient participating in another clinical study
• Protected patient: adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision
• Pregnant or breastfeeding woman
• Patient hospitalized without consent

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé La Louvière

Lille, 59000, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: February 3, 2022
• Primary Completion: November 4, 2024
• Study Completion: June 30, 2025
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

FR (1)