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临床试验/NCT07186712
NCT07186712已完成不适用

The Incidence of Early Trauma Induced Coagulopathy and Hyperfibrinolysis in Severely Injured Trauma Patients in the Emergency Room: a Retrospective Cohort Study

Medical University of Graz1 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2025年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
263
试验地点
1
主要终点
incidence of eTIC

研究概览

简要总结

The aim of this study is to quantify the incidence of eTIC (defined as an elevated appt) and hyperfibrinolysis (defined as Ly30>7) in early trauma patients. To identify patients at risk of eTIC and hyperfibrinolysis, we will conduct a systematic search for trauma patients with an ISS>16 in whom a thrombelastogram (TEG) was obtained in the emergency department (ED)

详细描述

Despite excessive efforts to reduce the number of preventable deaths in patients suffering from traumatic injuries, hemorrhage is still a leading cause of morbidity and mortality in this patient group. (1) The importance of trauma induced coagulopathy (TIC) on the extent of blood loss has been known at least since 1982. Where Kashuk et al. described the lethal triad of hypothermia, acidosis and coagulopathy for trauma patients. (2) In 2003 two landmark studies firstly identified that coagulopathy was present in the early phase after patients suffered severe traumatic injuries and prior to resuscitation efforts. In both studies the rate of early trauma induced coagulopathy (eTIC) was high (24.4% Brohi et al., 28% Macleod et al.), even in patients with relatively low median injury severity scores (mean ISS 20 and 9). Notably, both studies identified eTIC as an independent predictor of mortality. (3) (4) Nowadays, health care providers and guidelines heavily emphasis the importance of eTIC in trauma resuscitation. However, in a cohort study from Teeter et al. published in 2024 with the data of two major trauma centers in the US found that the incidence of eTIC (defined as the initial prothrombin time (PT) or partial thromboplastin time (PTT) above normal per each center's reference range) increased to 33.4% and that coagulopathy had a major impact on mortality over all severity ranges. (5) However, to detect trauma induced coagulopathy new technologies such as thrombelastography (TEG) and rotational thromboelastometry (ROTEM) have been implemented in the trauma algorithm of major trauma centers since 2003. These tests offer a rapid, comprehensive assessment of the dynamic and sequential processes involved in trauma-induced coagulopathy. (6) With the opportunity of early detection of different entities of eTIC including Hyperfibrinolysis, Thromelastography has shown to corresponded to a reduction in hospital length of stay, intensive care unit length of stay and cost of transfused blood products. (6)

2. Study objective 2.1 Primary Aim The aim of this study is to quantify the incidence of eTIC (defined as an elevated appt) and hyperfibrinolysis (defined as Ly30>7) in early trauma patients. To identify patients at risk of eTIC and hyperfibrinolysis, we will conduct a systematic search for trauma patients with an ISS>16 in whom a thrombelastogram (TEG) was obtained in the emergency department (ED)

The primary values of interest are:

  • Initial activated partial thrombin time (appt)
  • INR
  • TEG (R time, MA, Lyseindex 30)

2.2 Secondary objectives

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Age < 18 years
  • Sever trauma (ISS>16)
  • Coagulation parameters (PT, aPTT, INR, fibrinogen, TEG) available within the first hour of admission

排除标准

  • Patients with known pre-existing coagulopathies
  • Patients on anticoagulant therapy prior to trauma
  • Incomplete or missing coagulation data

研究组 & 干预措施

Patients in the trauma resuscitation bay of the Medical University of Graz

Valid thrombelastogramm available

结局指标

主要结局

incidence of eTIC

时间窗: 1 hour after admission

defined by increased appt/INR

次要结局

  • incidence of hyperfibrinolysis(1 hour after admission)
  • Correlation of standard laboratory abnormalities and TEG findings(1 hour after admission)
  • Correlation of eTIC and mortality(30 days)

研究者

发起方
Medical University of Graz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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