Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients

University Hospital, Grenoble0 个研究点目标入组 100 人开始时间: 2015年1月最近更新: 2016年8月17日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 100
主要终点: Concordance between POC INR and laboratory INR using 3 classes: normal < 1.1, moderate : 1.1-1.5, severe: >1.5

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

Traumatic coagulopathy is frequent and is an independent risk factor of mortality. Its detection mainly relies upon classic biological test like the prothrombin time and the international normaliezd ratio (INR). These tests are not available at the bedside. Point of care (POC) device for INR measurement are now available like the Coaguchek, Roche, France. The aim of the present study is to test the correlation between the POC INR and the laboratory INR.

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

年龄范围: 15 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age > 15 y-o
•Admission for severe trauma

排除标准

•Patients under oral anticoagulant

结局指标

主要结局

Concordance between POC INR and laboratory INR using 3 classes: normal < 1.1, moderate : 1.1-1.5, severe: >1.5

时间窗: Admission

次要结局

Organ failure measured with the SOFA score at Day 1(Day 1)
Injury severity (ISS)(Day 1)
Prediction of RBC transfusion(24 hours post admission)
Prediction of FFP transfusion(24 hours post admission)
In-hospital mortality assessed using patients' files(up to Day 28)

研究者

发起方

University Hospital, Grenoble

申办方类型

Other

责任方

Sponsor

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