跳至主要内容
临床试验/CTRI/2024/11/076212
CTRI/2024/11/076212已完成不适用

Use of IMPACT & CRASH prognostication models for traumatic brain injury: to predict outcome in Indian population, a pilot study,

Kovai Medical Center and Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年11月15日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
1. To calculate the 6-month mortality and unfavorable outcome as predicted by IMPACT model and CRASH model and to compare with the observed 6-month mortality and unfavourable as seen in those patients with moderate to severe traumatic brain injury patients.

研究概览

简要总结

This is a retrospective observational study to evaluate ability of IMPACT and CRASH TBI model in predicting six month outcome in moderate to severe TBI patients in middle and low income countries.Records of patients admitted with moderate to severe TBI with GCS less than or equal to 12 during time period from january 2021 to june 2024 and satisfying inclusion criteria will be included in the study.Records of those patients will be retrieved and data like age,motor response,pupillary response at admission,existence of prehospital hypoxia,development of hypotension,marshall CT classification and presence of major extracranial injury based on abbreviated injury score will be collected and based on these variables IMPACT model and CRASH model will be used to predict their six month outcome.Glassgow Outcome Scale (GOS) of these patients will be assesed at their routine follow up visit after six months of TBI or by telephonic interview.Glassgow Outcome Scale will be dichotomized as favourable  (GOS 4 to 5) VS unfavourable (GOS 1 to 3) vs Mortality (GOS 1).The prognostic ability of IMPACT and CRASH model in predicting 6 months  outcome will be assesed using appropriate statiscal model.

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

  • Patients admitted with a diagnosis of traumatic brain injury with a GCS of 12 or less.

排除标准

  • Hospital admission more than 6 hours post trauma.
  • Patients less than 18 years of age
  • Pregnant patients
  • GCS score affected by the presence of alcohol or drugs of abuse
  • GCS score of three with bilateral fixed and dilated pupils, or if their injury was believed to be non-salvageable.
  • Those patients with a pre-existing neurological disability that would not allow follow-up
  • Those patients without adequate data records.

结局指标

主要结局

1. To calculate the 6-month mortality and unfavorable outcome as predicted by IMPACT model and CRASH model and to compare with the observed 6-month mortality and unfavourable as seen in those patients with moderate to severe traumatic brain injury patients.

时间窗: at 6 months after TBI

次要结局

  • To calculate 14-day mortality and 6-month unfavourable(outcome as predicted by CRASH model with CT and without)

研究者

发起方
Kovai Medical Center and Hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Emy Ambooken

Kovai Medical Centre and Hospital,Coimbatore

研究点 (1)

Loading locations...

相似试验

To study the usefullness of IMPACT & CRASH outcome... | 临床试验