| CTRI Number |
CTRI/2017/12/010836 [Registered on: 11/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out how much deranged coagulation is prevalent in severe head injury patients and how does it affect their outcome |
|
Scientific Title of Study
|
Trauma induce coagulopathy: incidence, predictors and outcome in patient with isolated traumatic brain injury |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam Rani |
| Designation |
Postgraduate student |
| Affiliation |
PGIMER |
| Address |
Dr Poonam Rani Junior resident Department of Anaesthesia and intensive care PGIMER chandigarh India.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878688401 |
| Fax |
|
| Email |
Poonam.ronsa.22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Panda |
| Designation |
professor |
| Affiliation |
PGIMER |
| Address |
DR Nidhi panda,Professor department of anaesthesia and intensive care PGIMER chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009525 |
| Fax |
|
| Email |
nidhibp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Rani |
| Designation |
Postgraduate student |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive care PGIMER chandigarh India.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9878688401 |
| Fax |
|
| Email |
Poonam.ronsa.22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, PGIMER Chandigarh |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of medical education and research |
| Address |
Dept of Anaesthesia,4th floor,nehru hospital,PGIMER Chandigarh-160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Poonam Rani |
Trauma ICU,PGIMER |
PGIMER Sector 12,Chandigarh
Chandigarh
CHANDIGARH |
9878688401
poonam.ronsa.22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Post Graduate Institute of Medical Education and Research ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
isolated head injury ,admitted in icu, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
all moderate to severe isolated head injury patients admitted in trauma ICU of PGIMER admitted to hospital with in 24 hour of injury. |
|
| ExclusionCriteria |
| Details |
extremes of age,patients having liver disease or congenital coagulation disorders or major injuries at any other sites are excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of coagulopathy in isolated head injury patients admitted in trauma ICU of PGIMER Chandigarh |
Development of coagulopathy will be seen within 72 hours of admission to hospital by coagulation tests at an interval of 24 hours each. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predictors of coagulopathy and outcomes in patients developing coagulopathy |
July 2016to Dec 2017 |
|
|
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)
|
22/08/2016 |
| 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="1"
Months="6"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet publicated |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients of isolated head injury admitted to the casualty of PGIMER within 24 hrs of injury who were subsequently taken to the trauma ICU are enrolled in the study and their coagulation profile was observed at interval of 24 hrs for total of 72 hrs.patients were followed for 3months for their outcome telephonically after discharge from ICU and score calculated using GOS scoring system |