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Trial record 86 of 157 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Injuries

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
Sponsor:
Information provided by (Responsible Party):
Monty Khajanchi, Seth Gordhandas Sunderdas Medical College

Brief 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.

Condition or disease
Brain Injuries, Traumatic

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Mortality [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Monty Khajanchi +919224422992 monta32@gmail.com

Locations
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India
Seth GS Medical College and KEM Hospital Recruiting
Mumbai, Maharashtra, India, 400012
Contact: Monty Khajanchi    +919224422992    monta32@gmail.com   
Sub-Investigator: Asif Mulla         
Sub-Investigator: Devi Bavishi         
Sponsors and Collaborators
Seth Gordhandas Sunderdas Medical College

Publications:
Haagsma JA, Graetz N, Bolliger I, Naghavi M, Higashi H, Mullany EC, Abera SF, Abraham JP, Adofo K, Alsharif U, Ameh EA, Ammar W, Antonio CA, Barrero LH, Bekele T, Bose D, Brazinova A, Catalá-López F, Dandona L, Dandona R, Dargan PI, De Leo D, Degenhardt L, Derrett S, Dharmaratne SD, Driscoll TR, Duan L, Petrovich Ermakov S, Farzadfar F, Feigin VL, Franklin RC, Gabbe B, Gosselin RA, Hafezi-Nejad N, Hamadeh RR, Hijar M, Hu G, Jayaraman SP, Jiang G, Khader YS, Khan EA, Krishnaswami S, Kulkarni C, Lecky FE, Leung R, Lunevicius R, Lyons RA, Majdan M, Mason-Jones AJ, Matzopoulos R, Meaney PA, Mekonnen W, Miller TR, Mock CN, Norman RE, Orozco R, Polinder S, Pourmalek F, Rahimi-Movaghar V, Refaat A, Rojas-Rueda D, Roy N, Schwebel DC, Shaheen A, Shahraz S, Skirbekk V, Søreide K, Soshnikov S, Stein DJ, Sykes BL, Tabb KM, Temesgen AM, Tenkorang EY, Theadom AM, Tran BX, Vasankari TJ, Vavilala MS, Vlassov VV, Woldeyohannes SM, Yip P, Yonemoto N, Younis MZ, Yu C, Murray CJ, Vos T. The global burden of injury: incidence, mortality, disability-adjusted life years and time trends from the Global Burden of Disease study 2013. Inj Prev. 2016 Feb;22(1):3-18. doi: 10.1136/injuryprev-2015-041616. Epub 2015 Dec 3.

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Responsible Party: Monty Khajanchi, Assistant Professor, Department of General Surgery, Seth Gordhandas Sunderdas Medical College
ClinicalTrials.gov Identifier: NCT03932500     History of Changes
Other Study ID Numbers: EC/198/2017
U1111-1231-3772 ( Other Identifier: Universal Trial Registration )
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Monty Khajanchi, Seth Gordhandas Sunderdas Medical College:
Validation
Prognostic score
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System