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.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ligamentoplasty Hemoglobin

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Privé La Louvière

Lille, 59000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

Hemoglobin loss

Time frame: Day 0 (before intervention) and day 2 (post surgery)

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

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

A Randomized, Double-blind, Multicenter 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.

Acronym: EXACYLCA

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2025
First posted: Aug 7, 2026
Registry last updated: Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed