NCT03932500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

April 25, 2019

Last Update Submit

April 29, 2019

Conditions

Brain Injuries, Traumatic

Keywords

ValidationPrognostic score

Outcome Measures

Primary Outcomes (1)

  • Mortality

    14 days

Secondary Outcomes (2)

  • Morbidity

    6 months

  • Mortality

    6 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seth GS Medical College and KEM Hospital

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (7)

  • 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, Catala-Lopez 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, Soreide 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.

    PMID: 26635210BACKGROUND

  • Gururaj G. Epidemiology of traumatic brain injuries: Indian scenario. Neurol Res. 2002 Jan;24(1):24-8. doi: 10.1179/016164102101199503.

    PMID: 11783750BACKGROUND

  • Agrawal D, Singh PK, Sinha S, Gupta DK, Satyarthee GD, Misra MC. Remaining unconscious: The burden of traumatic brain injuries in India. J Neurosci Rural Pract. 2015 Oct-Dec;6(4):520-2. doi: 10.4103/0976-3147.165394.

    PMID: 26752896BACKGROUND

  • Lee KL, Pryor DB, Harrell FE Jr, Califf RM, Behar VS, Floyd WL, Morris JJ, Waugh RA, Whalen RE, Rosati RA. Predicting outcome in coronary disease. Statistical models versus expert clinicians. Am J Med. 1986 Apr;80(4):553-60. doi: 10.1016/0002-9343(86)90807-7.

    PMID: 3963036BACKGROUND

  • MRC CRASH Trial Collaborators; Perel P, Arango M, Clayton T, Edwards P, Komolafe E, Poccock S, Roberts I, Shakur H, Steyerberg E, Yutthakasemsunt S. Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ. 2008 Feb 23;336(7641):425-9. doi: 10.1136/bmj.39461.643438.25. Epub 2008 Feb 12.

    PMID: 18270239BACKGROUND

  • Roozenbeek B, Lingsma HF, Lecky FE, Lu J, Weir J, Butcher I, McHugh GS, Murray GD, Perel P, Maas AI, Steyerberg EW; International Mission on Prognosis Analysis of Clinical Trials in Traumatic Brain Injury (IMPACT) Study Group; Corticosteroid Randomisation After Significant Head Injury (CRASH) Trial Collaborators; Trauma Audit and Research Network (TARN). Prediction of outcome after moderate and severe traumatic brain injury: external validation of the International Mission on Prognosis and Analysis of Clinical Trials (IMPACT) and Corticoid Randomisation After Significant Head injury (CRASH) prognostic models. Crit Care Med. 2012 May;40(5):1609-17. doi: 10.1097/CCM.0b013e31824519ce.

    PMID: 22511138BACKGROUND

  • Collins GS, Ogundimu EO, Altman DG. Sample size considerations for the external validation of a multivariable prognostic model: a resampling study. Stat Med. 2016 Jan 30;35(2):214-26. doi: 10.1002/sim.6787. Epub 2015 Nov 9.

    PMID: 26553135BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Monty Khajanchi

CONTACT

+919224422992monta32@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of General Surgery

Study Record Dates

First Submitted

April 25, 2019

First Posted

April 30, 2019

Study Start

March 22, 2018

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)