Brain Injuries, TraumaticNCT03932500
Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model
An observational study of Brain Injuries, Traumatic, run by Seth Gordhandas Sunderdas Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 22 Mar 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Seth GS Medical College and KEM Hospital
Mumbai, Maharashtra, 400012
Monty Khajanchi, +919224422992, monta32@gmail.com
Asif Mulla
About this study
Official title: Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model in a Tertiary Care Public University Hospital
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.
Read the 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.
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Validation, Prognostic score
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 14 days
Secondary outcomes (2)
Morbidity
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.
Measured: 6 months
Mortality
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start22 Mar 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seth Gordhandas Sunderdas Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monty Khajanchi, Seth Gordhandas Sunderdas Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932500
- Sponsor's protocol ID
- EC/198/2017
- Other IDs
- U1111-1231-3772
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2019
- Last updated
- 30 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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, 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.
PubMed 26635210Gururaj G. Epidemiology of traumatic brain injuries: Indian scenario. Neurol Res. 2002 Jan;24(1):24-8. doi: 10.1179/016164102101199503.
PubMed 11783750Agrawal 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.
PubMed 26752896Lee 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.
PubMed 3963036MRC 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.
PubMed 18270239Roozenbeek 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.
PubMed 22511138Collins 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.
PubMed 26553135
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Traumatic Brain Injury and External Validation of CRASH Prognostic Model in a Tertiary Care Public University Hospital
- ClinicalTrials.gov ID
- NCT03932500
- Acronym / sponsor ID
- EC/198/2017
- Conditions
- Brain Injuries, Traumatic
- Keywords
- Validation, Prognostic score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seth Gordhandas Sunderdas Medical CollegeUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 14 days
2 secondary outcomes
Morbidity
Time frame: 6 months
Mortality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Background: PubMed 26635210Haagsma 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.
- Background: PubMed 11783750Gururaj G. Epidemiology of traumatic brain injuries: Indian scenario. Neurol Res. 2002 Jan;24(1):24-8. doi: 10.1179/016164102101199503.
- Background: PubMed 26752896Agrawal 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.
- Background: PubMed 3963036Lee 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.
- Background: PubMed 18270239MRC 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.
- Background: PubMed 22511138Roozenbeek 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.
- Background: PubMed 26553135Collins 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by Seth Gordhandas Sunderdas Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Monty Khajanchi (+919224422992, monta32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03932500, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.