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临床试验/CTRI/2024/06/068786
CTRI/2024/06/068786尚未招募不适用

Impact of altered consciousness at the time of presentation on the neurological outcome of patients with aneurysmal subarachnoid haemorrhage

Post Graduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年6月23日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
500
试验地点
1
主要终点
To study the impact of Glasgow Coma Score post resuscitation on the neurological outcome of patients with aneurysmal subarachnoid haemorrhage

研究概览

简要总结

Cerebral aneurysms are defined as dilations that occur at weak points along the arterial circulation within the brain. Around 85% of aneurysms are located in the anterior circulation, predominately at junctions or bifurcations along the circle of Willis. Rupture of these aneurysms cause subarachnoid haemorrhage.1

In India, the prevalence of intracranial aneurysm ranges from 0.75% to 10.3%.2

 Patients with high white blood cell count, multiple aneurysms, hypertension, GCS<9, GCS 9-12, modified Fisher grade 3 and 4 and Hunt-Hess grade 3 or more were found to have poor prognosis.3 Cardiac complications associated with aneurysmal subarachnoid haemorrhage include arrhythmia, myocardial infarction and even cardiac arrest. aSAH is also associated with pulmonary oedema, acute respiratory distress, septicaemia and acute renal failure. Rebleeding, delayed cerebral ischemia, seizures and hydrocephalus are examples of neurological complications.4

Reduced alertness, diminished wakefulness, and a decreased awareness of oneself and the environment all characterize impaired consciousness.5 After being admitted, none of the patients with a GCS motor score of 3 or less than 3 were still alive at 12 months according to a single centre retrospective study.6Sodhi et al in their study reported that WFNS grade at presentation as the most important predictor of outcome.7Chiang et al found that the patient’s worst clinical grade is most predictive of outcome, especially when the patient is assessed using the WFNS scale or the GCS.8 There are very few studies from India that have looked into the overall prognosis of aSAH patients especially those with altered consciousness. We hypothesize that patients with aneurysmal subarachnoid haemorrhagepresenting with altered consciousness at the time of hospital admission will have poor neurological outcome as compared to those with preservation of consciousness.

 Hypothesis of the study

Patients with aneurysmal subarachnoid haemorrhage presenting with altered consciousness at the time of hospital admission will have poor neurological outcome as compared to those with preserved consciousness.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Age 18 years and above Radiological confirmed aneurysmal subarachnoid haemorrhage Patients with aneurysmal subarachnoid haemorrhage undergoing surgical clipping/ endovascular obliteration Patients with aneurysmal subarachnoid haemorrhage not undergoing clipping/endovascular procedure.

排除标准

  • Consent withheld by patient or patient’s legal kin Patient less than 18 years of age.

结局指标

主要结局

To study the impact of Glasgow Coma Score post resuscitation on the neurological outcome of patients with aneurysmal subarachnoid haemorrhage

时间窗: 3 months from event

次要结局

  • To study & compare the impact of altered consciousness using 3 different scales on patients with aneurysmal subarachnoid haemorrhage(To study the impact of altered consciousness on the neurological outcome of patients with aneurysmal subarachnoid haemorrhage)

研究者

发起方
Post Graduate Institute of Medical Education and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Shreosee Das

PGIMER

研究点 (1)

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