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Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model

NCT03932500 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2019-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Brain Injuries, Traumatic

Sponsors & Collaborators

  • Seth Gordhandas Sunderdas Medical College

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-22
Primary Completion
2019-06-30
Completion
2019-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03932500 on ClinicalTrials.gov