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临床试验/NCT04877405
NCT04877405已完成不适用

Retrospective Study to Identify Correlations Between the Clinical Parameters, Analytics and Neuroimaging Data in Patients That Suffered of Intraparenchymal Cerebral Hemorrhage

Universitat Autonoma de Barcelona1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2021年5月10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
137
试验地点
1
主要终点
Hematoma growth

研究概览

简要总结

This is a retrospective observational study to investigate the clinical, analytical and neuroimaging data generated during routine clinical management of intracerebral hemorrhage. The study will review the data from about 500 patients attended during the last ten years in the Neurology Department of Hospital Parc Taulí de Sabadell.

The aim is to measure the size of the lesion in neuroimage (TC and MRI), the edema, the alterations in diffusion weighted images and to correlate this data with clinical parameters and analytical measurements. With this approach investigators plan to investigate the incidence of hematoma growth, the role of perilesional edema and diffusion changes, and the relation between neuroimaging findings and clinical outcome. The study also try to establish significant correlations between clinical and analytical data, the clinical outcome and and the magnitude of changes in neuroimaging.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who have been attended at the Hospital Parc Taulí for the last 10 years after presenting an intraparenchymal hemorrhage.
  • The patients have had to undergo a computed tomography at the admission and a cranial magnetic resonance during the hospitalization in the time course specified in point in the protocol
  • The patients must present in their clinical story the analytical determinations detailed in the protocol.

排除标准

  • Intracerebral hemorrhage secondary to head trauma
  • Intracerebral hemorrhage secondary to neoplasm

结局指标

主要结局

Hematoma growth

时间窗: 2 days

Difference of hematoma size between CT conducted at admission and MRI conducted during follow up

Correlation between hematoma growth and analytical parameters

时间窗: 2 days

Determine the analytical parameters related with hematoma growth

Correlation between clinical parameters and the size of alterations in DWI

时间窗: 2 days

Determine the relationship between clinical parameters and the size of alterations in DWI

Alterations in DWI

时间窗: 2 days

Size of alterations in diffusion weighted image

Correlation between analytical parameters and the size of alterations in DWI

时间窗: 2 days

Determine the relationship between analytical parameters and the size of alterations in DWI

Correlation between hematoma growth and clinical paramenters

时间窗: 2 days

Determine the clinical parameters related with hematoma growth

Correlation between perilesional edema size and clinical outcome

时间窗: 1 month

Determine the relationship between the size of edema and clinical outcome

Perilesional edema

时间窗: 2 days

Size of edema measured in FLAIR sequences

Correlation between clinical parameters and the size of edema measured in FLAIR sequences

时间窗: 2 days

Determine the relationship between clinical parameters and the size of edema

Correlation between analytical parameters and the size of edema measured in FLAIR sequences

时间窗: 2 days

Determine the relationship between analytical parameters and the size of edema

Correlation between hematoma growth and clinical outcome

时间窗: 1 month

Determine the impact of hematoma growth on clinical outcome

Correlation between the clinical parameters and clinical outcome

时间窗: 1 month

Determine the relationship between the clinical parametes and clinical outcome

Correlation between the analyticial parameters and clinical outcome

时间窗: 1 month

Determine the relationship between the analytical parametes and clinical outcome

Correlation between the size of DWI alterations and clinical outcome

时间窗: 1 month

Determine the relationship between the size of DWI alterations and clinical outcome

次要结局

未报告次要终点

研究者

发起方
Universitat Autonoma de Barcelona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Santiago Rojas Codina MD PhD

Principal investigator

Universitat Autonoma de Barcelona

研究点 (1)

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