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临床试验/NCT03699813
NCT03699813已完成不适用

Use of Rotational Thromboelastometry (ROTEM) in Pediatric Perioperative Medicine and Its Comparison With Standard Coagulation Tests aPTT/PT

University Hospital, Motol0 个研究点目标入组 45 人开始时间: 2015年2月2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
45
主要终点
analysing blood loss during surgery

研究概览

简要总结

Hemocoagulation management in perioperative bleeding is nowadays based on standard coagulation testing: activated partial thromboplastin time (aPTT), prothrombin time (PT), fibrinogen, D-dimers, platelets. An interest about viscoelastic coagulation testing methods is rising - use of rotational thromboelastometry (ROTEM) is mentioned in the newest European guidelines for hemostasis management. ROTEM has more advantages then standard tests. However, both tests have only grade 1C recommendation, and most of trials have been done on adults. The goal of the study is to compare a relationship between standard tests and ROTEM in pediatric patients in perioperative period to find out which test has better correlation with clinical status, to compare therapeutic strategies and time necessary for gain both of tests and to compare the difference in blood loss and blood products consumption in group treated by ROTEM versus standard tests. Reduced blood loss and amount of blood products transfusion is expected to be found in ROTEM group, representing lowering risk for the patient, all due to early evaluation of hemocoagulation and targeted therapy guided by ROTEM.

详细描述

Pediatric patients who underwent spine surgery (under 18 years old) will be recruited in our study.

Retrospective data will be analysed from these patient who underwent scoliosis surgery before ROTEM implementation to daily practice and after ROTEM implementation do daily practice in our department.

Time to available results of ROTEM versus aPTT/PT tests will be compared. Blood loss and blood products used in these both groups will be analysed and compared between 2 groups.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • pediatric patients after surgical correction of scoliosis

排除标准

  • patients older than 18 years

结局指标

主要结局

analysing blood loss during surgery

时间窗: 3 years

blood loss during scoliosis surgery will analysed in both groups

次要结局

  • analysing blood transfusion units consumption(3 years)
  • time to results of tests(3 years)

研究者

发起方
University Hospital, Motol
申办方类型
Other
责任方
Principal Investigator
主要研究者

Durila Miroslav MUDr. Ph.D.

associated professor

University Hospital, Motol

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