| CTRI Number |
CTRI/2018/04/012939 [Registered on: 02/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of relationship between Computed tomography (CT) findings and a general condition measuring scale in patients with head injury. |
|
Scientific Title of Study
|
A study of correlation of computed tomography(CT) findings and glassgow trauma scale in patients with head trauma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Urvi khambhati |
| Designation |
First year resident doctor |
| Affiliation |
Govt. Medical College & Sir Takhtasinhji Hospital |
| Address |
Room no. 8,Dept. of Radiology,
Govt. Medical College & Sir Takhtasinhji Hospital, jail road,
Bhavnagar-364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9408549167 |
| Fax |
|
| Email |
urvikhambhati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirit B Vaishya |
| Designation |
Professor & Head |
| Affiliation |
Govt. Medical College & Sir Takhtasinhji Hospital |
| Address |
Room no.8,Dept. of Radio diagnosis,
Govt. Medical College & Sir Takhtasinhji Hospital,
Bhavnagar-364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825989240 |
| Fax |
|
| Email |
kiritvaishya@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirit B Vaishya |
| Designation |
Professor & Head |
| Affiliation |
Govt. Medical College & Sir Takhtasinhji Hospital |
| Address |
Room no.8,Dept. of Radio diagnosis,
Govt. Medical College & Sir Takhtasinhji Hospital,
Bhavnagar-364001
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825989240 |
| Fax |
|
| Email |
kiritvaishya@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Radio diagnosis,
Govt. Medical College & Sir Takhtasinhji General Hospital,
Jail road,
Bhavnagar - 364001 |
|
|
Primary Sponsor
|
| Name |
Department of Radio diagnosis |
| Address |
Govt. Medical College & Sir Takhtasinhji General Hospital,
Jail road,
Bhavnagar - 364001 |
| Type of Sponsor |
Government medical college |
|
|
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 Urvi Khambhati |
sir takhtasinhji general hospital |
room no.8,department of radiodiagnosis,Sir Takhtasinhji Hospital, Bhavnagar-364001
Bhavnagar
GUJARAT |
9408549167
urvikhambhati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional review board government medical college-bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with head trauma within 24 hours., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who gives consent.
all age group.
patients with a history of head trauma. |
|
| ExclusionCriteria |
| Details |
patients who sustained head injury and did not have CT scans.
patients who had other neurosurgical diseases and sustained head injury on top of that.
when CT scans were ordered before the full assessment of the neurological status.
patients with head trauma for longer than 24 hours
pregnant patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient will be evaluated at the emergency department for Glasgow Coma Scale. then they will undergo CT scan if they need. and CT findings will be correlated with the Glasgow coma scale. |
withing 24 hours of trauma. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Age and gender wise analysis of data. |
within 24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/01/2017 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a cross sectional and observational study. and it will be carried out in Sir Takhtasinhji Hospital, Bhavnagar. Patients with head trauma will be brought to the emergency department and they will be evaluated for glasgow coma scale upon arrival at the emergency department.Patients will be send to undergo CT scan if they need it and then the CT findings and GCS will be matched and analysis will be done to find a correlation if there. Age wise and gender wise analysis will be made so that analysis of this study may be used to know possible CT findings in emergency department. |