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临床试验/CTRI/2021/09/036842
CTRI/2021/09/036842尚未招募不适用

FOUR Score in predicting the severity and outcome of Traumatic Brain Injury (TBI)compared to GCS

MOSC Medical College Hospital1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2021年1月10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
138
试验地点
1
主要终点
Nourological outcome which will be measured using GOS-E(Glasgow outcome scale extended) r unfavorable (score 1-4) or favorable (score5-8)

研究概览

简要总结

Traumatic braininjury is one of the leading causes of death and disability in patientsadmitted to the emergency department. The Glasgow Coma Scale (GCS) is themost widely accepted scale for assessing levels of consciousness, clinicalstatus, as well as prognosis of traumatic brain injury (TBI) patients. The FullOutline of UnResponsiveness (FOUR) score is a new coma scale developedaddressing the limitations of the GCS.

In this context this study aims to compare Four Score in predicting the severityand outcome of Traumatic Brain Injury (TBI) compared to GCS. By choosingthe best assessment methods, needed interventions can be made early and can belife saving to the patient.

GCS and FOUR score will be recorded during the primaryassessment in the ER followed by 24 hours post presentation. The FOUR score andGCS will be compared to the Marshall classification to find out which onecorrelates with severity of injury better. Data regarding usage of antiplatelets/anti coagulants prior to Traumatic brain injury will be collected. Itwill be compared to outcome to know if it interferes with outcome of TBI. GCSscoring includes eye opening, verbal and motor response for the assessment ofseverity of TBI. The primary outcomes will be measuredusing Glasgow outcome scale extended. Patients will be prospectively followed up and score will be recorded inGlasgow outcome scale extended (GOSE) at1 month and  3 month via telephone/face to face interview.Details collected includes data to analyze mortality and level of disabilitydue to the TBI. GOSE 1 (dead), GOSE 2 (vegetative state), GOSE 3 (lower severedisability), GOSE 4 (upper severe disability), GOSE 5 (lower moderatedisability), GOSE 6(upper moderate disability), GOSE 7 (lower good recovery), andGOSE 8 (upper good recovery). Our study tool will be a pre structured proformaand it consists clinical evaluations  anddiagnostic part.

The final outcomes will be decided eitherunfavorable (score 1-4) or favorable (score5-8).5 In    hospitalmortality and ICU length of stay will be assessed during this study. Patientswith other severe injuries other than traumatic brain injury will be excludedfrom the study if it is found to interfere with outcome at any stage of thestudy

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 98.00 Year(s)(—)
性别
All

入选标准

  • Patients above 18 years of age sustained TBI
  • Documented brain injury in CT scan.

排除标准

  • Patients sustained with non-traumatic brain injury
  • Those with documented pre-existing neurologic deficit 3.Patients with injuries other than TBI which interferes with outcome.

结局指标

主要结局

Nourological outcome which will be measured using GOS-E(Glasgow outcome scale extended) r unfavorable (score 1-4) or favorable (score5-8)

时间窗: At the end of 1st and 3rd month.

次要结局

  • In hospital mortality and ICU length of stay(At the time of discharge)

研究者

发起方
MOSC Medical College Hospital
申办方类型
Private medical college

研究点 (1)

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