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临床试验/NCT04167644
NCT04167644已完成不适用

Proper Timing of Control of Hypertension and Outcome in Acute Spontaneous Intracerebral Hemorrhage.

Mansoura University Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
CT brain

研究概览

简要总结

The ideal management of blood pressure in BP after acute intracerebral haemorrhage is still debated and whether a higher intensive reduction of blood pressure after acute intracerebral haemorrhage may be better or not is still controversial. Conflicting results from different randomized trials in regards to the clinical guidelines for management of hypertension in people with acute intracerebral hemorrhage (ICH). These results indicate that the management of BP and the prognosis after acute spontaneous ICH are very complicated.

Therefore, analysis based on actual blood pressure (BP) accomplished may be a more efficient method to assess the impact of BP management on outcome of ICH.

In our research, blood pressure (BP) management and prognosis were studied in patients with acute intracerebral hemorrhage to decide the perfect time control BP to improve outcome.

详细描述

Methods:

Patients were diagnosed by clinical examination and according to the initial CT brain after the onset of ICH.

Intensive management of blood pressure (BP) started once the diagnosis of intracerebral hemorrhage was established. Systolic blood pressure targeted 140 mm Hg by IV drug that lower BP like nicardipine or diltiazem. Oral antihypertensive medications like (Angiotensin II Receptor Blockers (ARBs) or Ca-blocker), after 24 h of hospitalization, was utilized in combination and step by step changed from intravenous administration.

Patients were exposed to:

A) Complete history taking and complete clinical assessment including neurological and general examinations.

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
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients incorporated into this study aged over 25 years of either sex with first spontaneous intracerebral hemorrhage (ICH).

排除标准

  • Secondary ICH were excluded from this study (like traumatic, hemorrhagic infarcts, AVM, bleeding tumors or SOL, or IVH only without ICH).
  • Patients with previous ischemic stroke or T1As

结局指标

主要结局

CT brain

时间窗: 24 hours

CT brain was accomplished for all patients at onset of admission to hospital to decide the characters of spontaneous intracerebral hemorrhage (ICH). The volume of the intracerebral hemorrhage was determined utilizing the ABC/2 method (A is the most great diameter on the most large ICH cut, B is the diameter perpendicular to A, while, C is the number of axial cuts of ICH multiplied by the thickness of cuts. Additionally, the location ICH (regardless of whether infra or supatrentorial), and if there is IVH or not, also, if there is shift of midline structure or hydrocephalic changes were determined. Regarding ICH volume, patients were partitioned into two groups (\< 30 cm3 and ≥30 cm3)

Glasgow Coma Scale score

时间窗: 24 hours

Initial Glasgow Coma Scale score at admission to hospital and patients according to GCS score were classified to 3 groups I (13-15), II (5-12), and III (3-4 ) according to Hemphill et al 2001.

次要结局

  • Modified Rankin Scale (mRS)(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Esmael

Assistant Prof of Neurology

Mansoura University Hospital

研究点 (1)

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