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出境医 / 临床实验 / Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model

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

Study Description
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

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Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Monty Khajanchi +919224422992 monta32@gmail.com

Locations
Layout table for location information
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
Tracking Information
First Submitted Date April 25, 2019
First Posted Date April 30, 2019
Last Update Posted Date April 30, 2019
Actual Study Start Date March 22, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2019)
Mortality [ Time Frame: 14 days ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 29, 2019)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model
Official Title Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model in a Tertiary Care Public University Hospital
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.
Detailed Description

Introduction As per World Health Organization (WHO) 2015 report, road injury is the tenth cause of mortality in the world[1]. 90% of these occur in Low and Middle-Income countries (LMICs)[2]. The complex interaction of human, vehicle and environmental factors along with lack of sustainable preventive programs has contributed to this 'silent epidemic' of injuries. Amongst Injuries, Traumatic Brain Injuries is the leading cause of morbidity and mortality.

The young working men of age 20-40 years are the most vulnerable group to suffer a Traumatic Brain Injury[3]. Around 60% of those with TBI do not resume work[3]. A study done in Delhi, India showed that patients with severe TBI who were unconscious at discharge, 50% of them died at six months and another 30% remained in vegetative state[4].

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. Researches have shown prognostic models are statistical models that combine data from patients to predict outcome are likely to be more accurate than simple clinical predictions[5]. A multicenter randomized control trial published a prediction model for traumatic brain injury patients[6]. Unlike other prediction models this model was based on data from High Income and Low Middle-Income Countries. However, the external validation of this prediction model was not done in LMICs data[7]. 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. e.g. A 45 year old male , came with road traffic accident leading to traumatic brain injury. His Glasgow Coma Scale was E4V4M5, both the pupils reacting to light and CT scan brain suggestive of Sub-dural hematoma of thickness approximately 3 mm along left basi-frontal superior and middle frontal convexities without significant underlying mass effect. These details inserted in CRASH PROGNOSTIC MODEL calculator as shown below. As per this the mortality at 14 day is 4.4% and morbidity at 6th month is 12.6% i.e. unfavorable outcome.

Data collection Data collection will be done by a resident and a medical student of the same hospital. Patients will be prospectively followed in the ward till discharge or death. Information will be entered in the case record form based on patients file. Written, valid informed consent will be taken to follow up patients on day 14th day and 6 months after the date of injury by telephonic conversation.

Outcomes:

Outcome of the study is mortality at 14th day and mortality and morbidity at 6th months after head injury. This morbidity at 6th months will be measured by using GLASGOW OUTCOME SCALE by telephonic conversation

Variables:

Demographic Variables, mechanism of injury, transfer status, vital parameters on admission like systolic blood pressure, heart rate, Glasgow coma scale will be noted from case records. Patients pupillary response will be collected from case record sheet. Ct scan findings and whether or not patient was operated (neurosurgery) will be noted. Other injuries will also be recorded.

Sample Size The sample size for an external validation study should have at least 100 patients with the outcome and 100 without the outcomes[8,]. The short-term outcome is mortality at 14 days. The mortality in all groups of TBI is 23%. So, to have 100 events we will need a sample size of minimum 500 patients. An interim analysis will be done at one year to see if the sample size is met and a further decision on the study duration will be made.

Analysis Data will be entered in Microsoft Excel 2016 and statistical analysis will be done using SPSS version 17. We will assess the performance of the models in our dataset in terms of discrimination and calibration. Discrimination describes how well a model distinguishes between patients with and without the outcome of interest. Calibration indicates how closely predicted outcomes match observed outcomes.

To assess discrimination, we will calculate the area under the receiver operating characteristic curve (AUC). An AUC of 1 implies perfect discrimination, whereas an AUC of 0.5 implies that a model's discrimination is no better than chance.

To assess calibration, we will plot observed versus predicted outcome. Ethics Informed consent will be taken by the co-investigator of this study from the patient/relative (legal representative), after patient is admitted in the ward. The informed consent will be to follow up the patient telephonically at 14 days and 6 months from the date of injury. During course in ward or at discharge if patient is conscious and is in a state to give consent, re-consent will be taken from patient himself. If the patient refuses to give consent then his/her data will not be recorded and no follow up will be done for the purpose of study.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Brain Injuries, Traumatic
Intervention Not Provided
Study Groups/Cohorts Not Provided
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.
  • Gururaj G. Epidemiology of traumatic brain injuries: Indian scenario. Neurol Res. 2002 Jan;24(1):24-8. Review.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 29, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT03932500
Other Study ID Numbers EC/198/2017
U1111-1231-3772 ( Other Identifier: Universal Trial Registration )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Monty Khajanchi, Seth Gordhandas Sunderdas Medical College
Study Sponsor Seth Gordhandas Sunderdas Medical College
Collaborators Not Provided
Investigators Not Provided
PRS Account Seth Gordhandas Sunderdas Medical College
Verification Date April 2019