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临床试验/NCT03247049
NCT03247049已完成不适用

Predicting Long Term Survival in Patients With Primary Intracerebral Hemorrhage. Development and Validation of the ICHCat in Primary Care.

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina0 个研究点目标入组 262 人开始时间: 2015年7月27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
262
主要终点
Death all causes

研究概览

简要总结

The clinical evidence shows that patients with a first episode of intracerebral hemorrhage (ICH) are increasingly old and with greater comorbidity with a recognized impact over mortality. The prediction of the outcome of ICH is not only crucial in the emergin attention to identify those patients with favorable criteria that can benefit from possible treatments; but also after hospital discharge, in primary care where the prediction should facilitate the organization and management of a wide variety of resources: familiar, health and social welfare. Even though there are different scales that predict mortality, these are not sufficiently useful in choosing a treatment or do not provide sufficient data to the family to decide.

Due to the characteristics of the population with ICH described in these works, it seems useful to propose a prognostic index (ICHCat) to identify the variables associated to its incidence and mortality and that, in addition, to make adjustments in the comparisons of the survival between different series of patients or different treatment modalities in primary care.

详细描述

The authors carried out a multicentric and retrospective study of a cohort with an episode of ICH in the period between 2006-2016. The objective of this phase is to design a predictive index (ICHCat) of mortality in patients with an episode of ICH. Patient outcome was followed until death all causes or study end (30.09.2016) since date of ICH in the electronic health record. All people included were managed by the Public Health System in Catalonia. Registry information was collected from the government-run healthcare provider responsible for all inpatient care in the county.

Predictor Variables

Predictor variables were considered if they were viewed as commonly measured and available in primary care and with potential evidence of an association with ICH risk. Candidate variables included:

Sex: woman (0) man (1) Age: <80 year-old (1), ≥80 year-old (2). Number CCP criteria: <4 (0) ≥4 (1). Charlson comorbidity index. Short version. Current medications were asked about during the home visit and confirmed in medical records. Polypharmacy (defined as five or more daily medications): <5 (0), between 5-9 (1), and ≥10 (2). Oral anticoagulants (acenocumarol or warfarin) with TTR ≥60% (1), if TRT <60% (2) or New Oral Anticoagulants NOACs (0). Antidepressants and/or, sedating or other drugs affecting the neurologic system: man (1), woman (2). If there was a diagnostic of "atrial fibrillation", CHA2DS2VASC and HAS-BLED scores were included.

Recurrent falls or fall risk: no (0), yes (1). Hypertension not controlled by therapy (≥ 160/90 mmHg): no (0), yes (1). BP was measured as an average of separated follow-up measurements last six months.

研究设计

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

入排标准

年龄范围
15 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have been suffered a Intracranial Hemorrhage

排除标准

  • <15 and >90 year-old

结局指标

主要结局

Death all causes

时间窗: Within 5 years follow-up after episode ICH

Death all causes

次要结局

未报告次要终点

研究者

发起方
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Lluís Clua Espuny

PhD

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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