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临床试验/NCT07753161
NCT07753161已完成不适用

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.

GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Hemoglobin loss

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Patient treated with Tranexamin acid

Experimental

干预措施: ACL reconstruction (Procedure)

Patient treated with placebo

Placebo Comparator

干预措施: ACL reconstruction (Procedure)

结局指标

主要结局

Hemoglobin loss

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
GCS Ramsay Santé pour l'Enseignement et la Recherche
申办方类型
Other
责任方
Sponsor

研究点 (1)

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