| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S068||Other specified intracranial injuries, |
|
|
Intervention / Comparator Agent
|
|
|
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. |