| CTRI Number |
CTRI/2024/11/077138 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE LONGITUDINAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
A study of the significance of blood cells (their size , volume and distribution )in a patient suffering from Stroke and their effect on the severity of the stroke |
|
Scientific Title of Study
|
A Study of Clinical significance of Platelet Indices in Acute Ischemic Stroke and its effect on clinical outcome- an Observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GOVIND PS |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KMC, MANIPAL |
| Address |
DEPARTMENT OF GENERAL MEDICINE, KMC, MADHAV NAGAR, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
8073938340 |
| Fax |
|
| Email |
govindsprabha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHIVASHANKAR KN |
| Designation |
PROFESSOR AND HEAD OF THE UNIT |
| Affiliation |
KMC MANIPAL |
| Address |
DEPARTMENT OF GENERAL MEDICINE, KMC, MADHAV NAGAR, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9448623861 |
| Fax |
|
| Email |
shishamed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHIVASHANKAR KN |
| Designation |
PROFESSOR AND HEAD OF THE UNIT |
| Affiliation |
KMC MANIPAL |
| Address |
DEPARTMENT OF GENERAL MEDICINE, KMC, MADHAV NAGAR, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9448623861 |
| Fax |
|
| Email |
shishamed@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF GENERAL MEDICINE, KMC , MADHAV NAGAR, MANIPAL, KARNATAKA , INDIA, 576104 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF GENERAL MEDICINE, KASTURBA MEDICAL COLLEGE, MANIPAL |
| Address |
DEPARTMENT OF GENERAL MEDICINE, KMC , MADHAV NAGAR, MANIPAL, KARNATAKA , INDIA, 576104 |
| Type of Sponsor |
Private 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 |
| GOVIND PS |
KASTURBA HOSPITAL , MANIPAL |
DEPARTMENT OF GENERAL MEDICINE,KASTURBA HOSPITAL , MANIPAL
Udupi
KARNATAKA |
8073938340
govindsprabha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE- 2 (STUDENT RESEARCH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
ANYBODY WHO IS ABOVE THE AGE OF 18 YEARS AND DIAGNOSIS OF ISCHEMIC STROKE CONFIRMED BY CRANIAL CT OR MRI WITHIN THE FIRST 24 HOURS OF THE DISEASE APPEARANCE |
|
| ExclusionCriteria |
| Details |
Hemorrhagic Stroke, Previous Stroke, TIA, Head Trauma, Previous Brain surgery , CNS Infection
CKD
CLD
Post CABG
HIV-AIDS Patients
Autoimmune diseases / positive CRP/ Acute infection
Anti-Platelet , Anti-lipids, ACE inhibitors, Anticoagulants, Hydroxyurea
Anticancer drugs
PVD
Leukemia / Thrombocytopenia / Vit B12 deficiency/ MPS / ITP
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the Mean platelet Volume (MPV), Platelet Distribution Width (PDW) Plateletcrit (PCrt), Platelet-to-White Blood Cell Ratio (PWR) and Platelet to Lymphocyte ratio (PLR).
To assess Verity of ischemic stroke by the National Institute of Health Stroke Scale (NIHSS)
Analyze the association between MPV, PDW, PCrt, PWR and PLR with NIHSS |
PROSPECTIVE LONGITUDINAL STUDY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Analyze the effect of comorbid illnesses such as Diabetes, Hypertension, Dyslipidemia on Platelet indices in ischemic Stroke. |
PROSPECTIVE LONGITUDINAL STUDY |
|
|
Target Sample Size
|
Total Sample Size="133"
Sample Size from India="133"
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)
|
29/11/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prospective, Cross sectional, Non-interventional Observational study c patients with Acute Ische Stroke in Tertiary care teaching hospital KMC Manipal 10 Cases definition: rapidly developing clinical symptoms or signs of focal or global loss of cerebral function with symptoms lasting for more than 24 hours. Cases included in the study are patients admitted in the medical wards who are diagnosed to have stroke based on the above definition and who meet the inclusion criteria.
Each patient is assessed and severity of stroke is stratified using the NIHSS at time of Presentation and at Discharge time / after 7 days. |