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临床试验/NCT06364059
NCT06364059已完成不适用

A Comparative Analysis of Prognostic Factors for Functional Outcomes in Patients With Acute Subdural Hematoma

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2024年6月1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
175
试验地点
1
主要终点
Chronic use of anti-clotting medication

研究概览

简要总结

Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes.

详细描述

Acute subdural hematoma (ASDH) is the most common intracranial traumatic lesion that requires surgical intervention. Although there is extensive published research on acute subdural, there remains uncertainty regarding mortality risk and functional outcomes for patients. This study aims to evaluate the effectiveness of contemporary scoring systems in different age groups of ASDH patients to predict functional outcomes. It is our belief that this research will provide valuable insights on the risk of mortality and functional outcomes for ASDH patients. Several clinical and radiologic factors have been identified within the general population that correlate with mortality rates and functional outcomes. There are a number of factors that must be considered in the evaluation of a patient with traumatic brain injury, and a comprehensive assessment is necessary to determine the best course of treatment.

研究设计

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

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

  • surgery due to ASDH
  • 12 months of follow-up
  • functional outcome measured by the Glasgow Outcome Scale Extended (GOSE).

排除标准

  • 未提供

结局指标

主要结局

Chronic use of anti-clotting medication

时间窗: once at time of admission

The number of patients on chronic anticoagulation therapy will be the subject of analysis.

Severity of illness analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II)

时间窗: within 24 hours of admission

Severity of patient illness will be analyzed using Acute Physiology and Chronic Health Evaluation II score (APACHE II) which ranges from 0 to 71 points. Higher scores correspond to more severe disease and a higher risk of death.

Initial size of subdural hematoma

时间窗: through study completion, an average of 1 year

Initial size of subdural hematoma measured in millimetres using CT scan.

Trauma severity analyzed using Injury Severity Score (ISS).

时间窗: once at time of admission

Trauma severity analyzed using Injury Severity Score. The ISS scores ranges from 1 to 75 points (Higher scores correspond to more severe injury and a higher risk of death).

Level of consciousness at time of injury

时间窗: through study completion, an average of 1 year

The level of consciousness (using the Glasgow Coma Scale, 3-15 points, higher score means a better outcome) at the time of injury is analyzed.

Initial midline shift

时间窗: through study completion, an average of 1 year

Initial size of midline shift measured in millimetres using CT scan.

The Glasgow Outcome Scale (GOS) at the time of discharge from the Intensive Care (IC).

时间窗: through study completion, an average of 1 year

The Glasgow Outcome Score allowing the objective assessment of the patient´s recovery after trauma brain injury. Allows a prediction of the long-term course of rehabilitation to return to work and everyday life. It uses five categories: 1. Death, 2. Persistent vegetative state, 3. Severe disability, 4. Moderate disability, 5. Low disability.

The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 12 months.

时间窗: 12 months follow up

The Glasgow Outcome Scale Extended (GOSE) is an expanded version of the Glasgow Outcome Scale for evaluation of global disability and recovery after traumatic brain injury. It uses eight categories: 1. Death, 2. Vegetative state, 3. Lower severe disability, 4. Upper severe disability, 5. Lower moderate disability, 6. Upper moderate disability - some disability but can potentially return to some form of employment, 7. Lower good recovery - minor physical or mental defect, 8. Upper good recovery - full recovery. A GOSE analysis will be performed on a patient who has undergone evacuation of a subdural hematoma 12 months after the trauma.

The Glasgow Outcome Scale Extended (GOSE) evaluation of global disability and recovery after 6 months.

时间窗: 6 months follow up

The Glasgow Outcome Scale Extended (GOSE) is an expanded version of the Glasgow Outcome Scale for evaluation of global disability and recovery after traumatic brain injury. It uses eight categories: 1. Death, 2. Vegetative state, 3. Lower severe disability, 4. Upper severe disability, 5. Lower moderate disability, 6. Upper moderate disability - some disability but can potentially return to some form of employment, 7. Lower good recovery - minor physical or mental defect, 8. Upper good recovery - full recovery. A GOSE analysis will be performed on a patient who has undergone evacuation of a subdural hematoma 6 months after the trauma.

次要结局

  • Time of operation.(up to 4 hours)
  • Number of revisions.(24 hours)
  • The need for reversal of the effects of anticoagulants.(24 hours)
  • Time from injury to surgery.(24 hours)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michal Soták

Principal investigator

Charles University, Czech Republic

研究点 (1)

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