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临床试验/NCT06097611
NCT06097611尚未招募早期 1 期

Efficacy and Outcome of Early Administration of Tranexamic Acid in Pediatric Polytraumatized Patients

Assiut University0 个研究点目标入组 74 人开始时间: 2023年11月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
74
主要终点
Determine the mortality rate among polytraumatic pediatrics who received Tranexamic acid within 3 hours versus those who did not received

研究概览

简要总结

The study will compare mortality and blood transfusion amounts among severely polytraumatized pediatrics who did or did not receive tranexamic acid within 3 h of injury, based on Injury Severity Score (ISS) and indicators of coagulopathy and fibrinolysis.

详细描述

Trauma is a leading cause of mortality in the pediatric population. In 2008, the American Academy of Pediatrics noted that trauma accounts for more deaths than all other causes combined . Bleeding remains the most preventable cause of death after trauma. A major recent advance was the recognition that coagulation defects are greatly responsible for the disproportional mortality caused by bleeding. Managing coagulation defects has become a forefront issue in trauma and novel strategies proposed include hemostatic resuscitation, adoption of massive transfusion protocols and other innovations , most with little evidence to support them. The exception is the proposal to administer tranexamic acid (TXA) to bleeding adult trauma patients.

To date, no medical treatment has been shown to reduce mortality in the setting of pediatric trauma; however, this evidence does exist in adults. Bleeding and coagulopathy due to trauma are associated with mortality in both adults and children. Clinical research has demonstrated a reduction in trauma-related mortality with early use of TXA in adult patients in both civilian and military settings . In adult patients with hemodynamic instability and ongoing bleeding, TXA is expected to save 1 in 67 lives . There is no scientific or biological reason to suggest that a similar mortality benefit will not be seen in pediatric trauma. The investigators feel the incorporation of TXA into pediatric trauma management has the potential to also significantly reduce mortality in children and youths, without increasing adverse events. This review explores the hematologic differences and similarities between injured children and adults, and the idea that TXA may be a novel and promising treatment in pediatric hemorrhagic trauma despite the current lack of evidence for its use in this setting.

TXA is an antifibrinolytic that reversibly binds to plasminogen at the lysine binding site, thus preventing the binding of plasmin (ogen) to fibrin and the subsequent degradation of fibrin . It is a generic, inexpensive medication used to prevent fibrin breakdown and reduce bleeding in various clinical settings (including orthopedic and cardiovascular surgery, post-partum hemorrhage, gastrointestinal hemorrhage, epistaxis, certain ophthalmologic conditions and other obstetric/gynecologic emergencies)

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • age 2-18 years
  • both genders
  • polytraum a

排除标准

  • age < 2 OR >18 years
  • period from injury to admission >6 hours
  • comorbidity with bleeding disorder, malignancy.
  • Patients receiving anticoagulant drugs.

研究组 & 干预措施

Efficacy of early Tranexamic Acid in Pediatric Polytraumatized Patients

Experimental

干预措施: Tranexamic Acid administration (Drug)

Efficacy of Early Tranexamic Acid in Pediatric Polytraumatized Patients

Active Comparator

干预措施: Tranexamic Acid administration (Drug)

结局指标

主要结局

Determine the mortality rate among polytraumatic pediatrics who received Tranexamic acid within 3 hours versus those who did not received

时间窗: 1 yaer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaaban Hassan Hassan Salim

Principal investigator

Assiut University

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