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临床试验/NCT03932500
NCT03932500Unknown不适用

Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model in a Tertiary Care Public University Hospital

Seth Gordhandas Sunderdas Medical College1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年3月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
Mortality

研究概览

简要总结

As per World Health Organization (WHO) 2015 report, road injury is the tenth cause of mortality in the world.

  • 90% of these occur in Low and Middle-Income countries (LMICs)
  • Amongst Injuries, Traumatic Brain Injuries is the leading cause of morbidity and mortality.
  • Clinicians have to answer about the prognosis of the injured patient to the anxious near ones on arrival as well as throughout the course of treatment
  • A multicenter randomized control trial (CRASH)published a prediction model for traumatic brain injury patients
  • This model was based on data from High Income countries and not from Low and Middle-Income Countries
  • Hence to fill this gap we aim to study the outcome of patients with Traumatic Brain Injury and also validate the CRASH trial prediction model in traumatic brain injury patient
  • It is a Prospective Observational Study for a duration of 18 months and the sample size is 500 patients.
  • Acute Traumatic Brain injury patients >18 years of age admitted in Emergency surgery room.
  • Patients with chronic head injury and Patients who have been declared brain dead and whose organs have been retrieved are excluded.
  • Variable are Age, Glasgow coma score, Pupils reaction to light, Major extra cranial injuries, CT Finding.
  • Outcome of the study is mortality at 14th day and morbidity and mortality after 6 months of head injury.

详细描述

Introduction As per World Health Organization (WHO) 2015 report, road injury is the tenth cause of mortality in the world[1]. 90% of these occur in Low and Middle-Income countries (LMICs)[2]. The complex interaction of human, vehicle and environmental factors along with lack of sustainable preventive programs has contributed to this 'silent epidemic' of injuries. Amongst Injuries, Traumatic Brain Injuries is the leading cause of morbidity and mortality.

The young working men of age 20-40 years are the most vulnerable group to suffer a Traumatic Brain Injury[3]. Around 60% of those with TBI do not resume work[3]. A study done in Delhi, India showed that patients with severe TBI who were unconscious at discharge, 50% of them died at six months and another 30% remained in vegetative state[4].

Clinicians have to answer about the prognosis of the injured patient to the anxious near ones on arrival as well as throughout the course of treatment. Researches have shown prognostic models are statistical models that combine data from patients to predict outcome are likely to be more accurate than simple clinical predictions[5]. A multicenter randomized control trial published a prediction model for traumatic brain injury patients[6]. Unlike other prediction models this model was based on data from High Income and Low Middle-Income Countries. However, the external validation of this prediction model was not done in LMICs data[7]. Hence to fill this gap we aim to study the outcome of patients with Traumatic Brain Injury and also validate the CRASH trial prediction model in traumatic brain injury patient. e.g. A 45 year old male , came with road traffic accident leading to traumatic brain injury. His Glasgow Coma Scale was E4V4M5, both the pupils reacting to light and CT scan brain suggestive of Sub-dural hematoma of thickness approximately 3 mm along left basi-frontal superior and middle frontal convexities without significant underlying mass effect. These details inserted in CRASH PROGNOSTIC MODEL calculator as shown below. As per this the mortality at 14 day is 4.4% and morbidity at 6th month is 12.6% i.e. unfavorable outcome.

Data collection Data collection will be done by a resident and a medical student of the same hospital. Patients will be prospectively followed in the ward till discharge or death. Information will be entered in the case record form based on patients file. Written, valid informed consent will be taken to follow up patients on day 14th day and 6 months after the date of injury by telephonic conversation.

Outcomes:

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

  • Adults with age more than 18 years presenting with acute Traumatic Brain Injury to the emergency surgical services of King Edward Memorial Hospital, Parel, Mumbai and get admitted will be enrolled in the study.

排除标准

  • Patients with chronic head injury will be excluded. Patients who have been declared brain dead and whose organs have been retrieved will be excluded from the study.

结局指标

主要结局

Mortality

时间窗: 14 days

次要结局

  • Morbidity(6 months)
  • Mortality(6 months)

研究者

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

Monty Khajanchi

Assistant Professor, Department of General Surgery

Seth Gordhandas Sunderdas Medical College

研究点 (1)

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