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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 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-07

No results posted yet for this study

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

Interventions

PROCEDURE

ACL reconstruction

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.

Sponsors & Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-03
Primary Completion
2024-11-04
Completion
2025-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07753161 on ClinicalTrials.gov