Clinical Research Directory

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.

Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Official 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.

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