跳至主要内容
临床试验/NCT04063982
NCT04063982已完成不适用

Diagnosis-related Outcomes in NeurocriTical Care: Prognostic Estimate by Health-care Providers Versus Risk Scores in Intracerebral and Subarachnoid Hemorrhage

University of Leipzig10 个研究点 分布在 1 个国家目标入组 1,085 人开始时间: 2019年12月12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
1,085
试验地点
10
主要终点
Modified Rankin Scale dichotomized 0-2 versus 3-6 at 6 months

研究概览

简要总结

The aim of the observational multicenter trial encompasses the comparison of estimation of the long-term prognosis (functional and cognitive outcomes, quality of life) after intracerebral and subarachnoid hemorrhages assessed by clinical scores, treating physicians and nurses. The scores and the assessment of the treating physicians and nurses are recorded on admission, at 7 and 14 days after symptom onset.

详细描述

The physicians and nurses responsible for the individual patient's care will be given a questionaire. They are asked to estimate the functional and cognitive status as well as quality of life of their patient. The patient with intracerebral hemorrhage and subarachnoid hemorrhage is examined and assessed with respective established and validated prognostic scores and models at the same time points.

The actual prognosis is assessed by telephone interview and questionaires at 3 and 6 months, either from the patient or his/her caretaker.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Spontaneous intracerebral hemorrhage or nontraumatic subarachnoid hemorrhage
  • Treatment in Centers with neurocritical care expertise

排除标准

  • Language other than German and English
  • Restriction of diagnostic and therapeutic measures during acute hospitalization according to advanced directives
  • Admission > 48 hours after symptom onset
  • Hemorrhage due to trauma

结局指标

主要结局

Modified Rankin Scale dichotomized 0-2 versus 3-6 at 6 months

时间窗: 6 months

Modified Rankin Scale dichotomized 0-2 (good functional outcome) versus 3-6 (poor functional outcome)

次要结局

  • Modified Rankin Scale dichotomized 0-3 versus 4-6 at 6 months(6 months)
  • Modified Rankin Scale dichotomized 0-3 versus 4-6 at 3 months(3 months)
  • Quality of life measured by Short Form Health Survey Short Form (SF)-36(3 and 6 months)
  • Quality of life measured by Sickness Impact Profile(3 and 6 months)
  • Cognitive outcome Telephone Interview for Cognitive Status(3 and 6 months)
  • Modified Rankin Scale dichotomized 0-2 versus 3-6 at 3 months(3 months)

研究者

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

研究点 (10)

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