跳至主要内容
临床试验/NCT06490978
NCT06490978尚未招募不适用

Predictors of Early Hematoma Expansion in Patients With Acute Intracerebral Hemorrhage (Clinical and Laboratory Study)

Assiut University0 个研究点目标入组 100 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
primary (main): appropriate predictor of hematoma expansion and poor outcomes with good accuracies.

研究概览

简要总结

This study aim to develop inflammatory score based on proper integration of several inflammatory markers and investigate whether it was associated with hematoma expansion and poor outcomes in patients with ICH .

详细描述

Intracerebral hemorrhage(ICH) accounts for approximately a quarter of all stroke subtypes with high mortality and the survi- vors always have varying degrees of residual disability. However, few medical and surgical treatments are clearly beneficial comparing with ischemic stroke. Hematoma expansion, which is a determinant of poor outcomes, occurs in about 30% of ICH patients especially at the early stage. Attenuating hema- toma expansion is a compelling target for ICH treatment, while the outcomes have not been accordingly improved after curbing the growth of hematoma in several clinical trials. It will be more helpful if a predictor can identify the risk of hematoma expansion and poor outcome rapidly and accurately. Thus the antiexpansion treatment to the patients with positive of such predictor is likely to provide clinical benefits.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • patients having spontaneous ICH aged 18 years or older admitted to a stroke unit within 24 hours After symptom onset .

排除标准

  • 1- patient have secondary ICH (cerebral aneurysm, Moyamoya syndrome, arteriovenous malformation, tumor, trauma or hemorrhagic transformation from brain infarction); (2)patient have primary intraventricular hemorrhage (IVH); (3)patients with historical modified Rankin scale (mRS) score greater than 1 (4) patient refused to be enrolled.

结局指标

主要结局

primary (main): appropriate predictor of hematoma expansion and poor outcomes with good accuracies.

时间窗: Baseline

The current study suggests inflammatory score consisting of appropriate integration of NLR, PLR, MLR, SII, LDH, and CRP is independently associated with hematoma expansion and poor outcomes of different terms in ICH patients, including secondary neurological deterioration within 48 hours, 30-day mortality, and 3-month poor mRS. Moreover, inflammatory score greater than or equal to 5 is validated as an appropriate predictor of hematoma expansion and poor outcomes with good accuracies

次要结局

  • Secondary outcome(One year)

研究者

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

Ahmed Hussein Abd El-samee

Resident doctor

Assiut University

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