Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model
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|ClinicalTrials.gov Identifier: NCT03932500|
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 2019
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.
|Condition or disease|
|Brain Injuries, Traumatic|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model in a Tertiary Care Public University Hospital|
|Actual Study Start Date :||March 22, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
- Mortality [ Time Frame: 14 days ]
- Morbidity [ Time Frame: 6 months ]The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead (1), Vegetative State (2), Severe Disability(3), Moderate Disability (4) or Good Recovery (5). 1 is the worst and 5 is the best.
- Mortality [ Time Frame: 6 months ]The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead (1), Vegetative State (2), Severe Disability(3), Moderate Disability (4) or Good Recovery (5). 1 is the worst and 5 is the best.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932500
|Contact: Monty Khajanchifirstname.lastname@example.org|
|Seth GS Medical College and KEM Hospital||Recruiting|
|Mumbai, Maharashtra, India, 400012|
|Contact: Monty Khajanchi +919224422992 email@example.com|
|Sub-Investigator: Asif Mulla|
|Sub-Investigator: Devi Bavishi|