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CTRI Number  CTRI/2022/08/044909 [Registered on: 25/08/2022] Trial Registered Prospectively
Last Modified On: 06/08/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of outcome in patients of head injury in Trauma Care Center 
Scientific Title of Study   “Assessment of outcome in patients of head injury in Level II Trauma Care Centre: A prospective observational study” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  B.J. Medical College and sassoon general hospitals, Pune 
Address  Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001

Pune
MAHARASHTRA
411001
India 
Phone  09022177719  
Fax    
Email  bjsujit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  B.J. Medical College and sassoon general hospitals, Pune 
Address  Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001

Pune
MAHARASHTRA
411001
India 
Phone  09022177719  
Fax    
Email  bjsujit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sujit Kshirsagar 
Designation  Assistant Professor 
Affiliation  B.J. Medical College and sassoon general hospitals, Pune 
Address  Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001

Pune
MAHARASHTRA
411001
India 
Phone  09022177719  
Fax    
Email  bjsujit@gmail.com  
 
Source of Monetary or Material Support  
B.J.Govt.Medical college, Pune 
 
Primary Sponsor  
Name  Dr Sujit Kshirsagar 
Address  Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujit J Kshirsagar  Trauma ICU, Trauma care center,B. J. Govt. MEDICAL COLLEGE and SASSOON GENERAL HOSPITALS, PUNE   Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001
Pune
MAHARASHTRA 
09022177719

bjsujit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, B. J. Govt. MEDICAL COLLEGE, SASSOON GENERAL HOSPITALS, PUNE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S068||Other specified intracranial injuries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients between age 18 to 65 yrs.
2. Patients admitted in Trauma intensive care unit
 
 
ExclusionCriteria 
Details  1. Patients more than 65 years of age. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to assess the outcome of head injury patients in level II trauma care centre.  at the time of admission,24 hrs,48 hrs,72 hrs, 96 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the outcome after operative management.
2) to assess the outcome after conservative management
3) to assess the outcome in mild, moderate and severe traumatic head injury
 
At the time of admission, till discharge/death 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Suspended 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Head injury is the most common cause of death following road traffic accidents globally. [1,2] Annually, 150‑200 people per million are disabled because of head injury. People under the age of 18 and 45 are most commonly affected. [3,4] In 2015, there were about five lakh road accidents in India, which killed about 1.5 lakh people and injured about five lakh people. [5] In 2020, 132 thousand deaths occurred due to road traffic accident. [6] About three to five percent of the GDP was invested in road accidents each year. India roughly accounts for just about one percent of the global vehicle population. However, it accounted for about six percent of the total global road accidents in 2020. [6] Majority of accidents (78.4%) are caused due to driver’s fault. This includes over speeding, driving under the influence of alcohol or drugs, and hit and run cases. Other causes of road accidents include fault of others (7.1%) such as fault of cyclists, pedestrians or drivers of other vehicles.  Fewer accidents are caused due to neglect of civic bodies (2.8%), defect in motor vehicle (2.3%), and poor weather conditions (1.7%). [6]

However, resources have not been diverted adequately by governments towards prevention,

management and rehabilitation of head injuries in developing countries such as India. [7] In this study we attempt to assess the burden and outcome of head injury at level II trauma care centre in Maharashtra. 

 
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