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临床试验/NCT06088407
NCT06088407已完成不适用

Tranexamic Acid Prophylaxis for Heterotopic Ossification in Elbow Fracture-Dislocation Surgery: A Prospective Randomized Trial

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年2月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Presence of Heterotopic Ossification in plain radiographs

研究概览

简要总结

Heterotopic ossification (HO) following elbow fracture-dislocation is a well-recognized condition that can lead to reduced range of motion, increased pain, and the necessity for repeat surgeries.

Inflammation serves as a pivotal initiating factor in the formation of (HO) following a traumatic event. The inflammatory cascade triggered can lead to the dysregulation of tissue homeostasis, thereby promoting the aberrant formation of ectopic bone. Tranexamic acid (TXA), a Food and Drug Administration (FDA) approved synthetic antifibrinolytic agent, has garnered significant attention for its potential to mitigate the inflammatory response in the context of orthopaedic surgical procedures.

This study aims to investigate the hypothesis that reducing soft tissue hematoma during elbow fracture-dislocation surgery through the intraoperative administration of TXA, can alleviate the occurrence or severity of ectopic bone formation.

Methods: A prospective randomized study was conducted on patients with elbow fracture-dislocation who underwent surgery between 2016 and 2022. A total of 50 patients were enrolled and randomly assigned to two groups. The first group received 1 gram of intravenous tranexamic acid before the operation, followed by an additional 1 gram intravenously during wound closure. The second group did not receive any anti-bleeding medication. Patients were followed up at intervals of 2 weeks, 6 weeks, 3 months, and as needed after the surgery. At the end of the follow-up period, there were 23 patients in the first group and 24 in the second group, with a median follow-up duration of 12.7 months. All patients did not receive any other form of HO prophylaxis. Postoperative radiographs and clinical outcomes were assessed and recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • traumatic non-pathological elbow fracture-dislocation.
  • age 18 years or older.
  • presentation within 2 weeks of injury.
  • Willingness to participate in the study

排除标准

  • Inability to provide consent for research participation.
  • Active infection in the operated limb.
  • Previous hip fracture.
  • Head injury.
  • History of deep vein thrombosis (DVT).
  • History of venous thromboembolism (VTE).
  • Ischemic heart event within the last six months.
  • Stroke (CVA) within the last six months.
  • Coagulopathies.

研究组 & 干预措施

With tranexamic acid

Experimental

Patient undergoing surgery for elbow fracture-dislocation randomized to be treated with tranexamic acid intraoperatively.

The patients received intravenous 1 gram tranexamic acid in 100ml normal saline 30 minutes before skin incision and a second dose of intravenous 1 gram tranexamic acid in 100 ml of normal saline during wound closure.

干预措施: with Tranexamic acid (Drug)

结局指标

主要结局

Presence of Heterotopic Ossification in plain radiographs

时间窗: 2 weeks- 1 year

Heterotopic Ossification presence, defined as new bone formation that had not been present in the imaging studies made at the time of the injury

次要结局

  • Functional elbow Range of motion assessment(2 weeks - 1 year)
  • Heterotopic Ossification Classification System Score(2 weeks - 1 year)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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