| CTRI Number |
CTRI/2026/04/109135 [Registered on: 23/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Platelet Blood Test Changes in Patients with Acute Stroke. |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY OF PLATELET INDICES IN PATIENT WITH ACUTE CEREBROVASCULAR ACCIDENT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajeev Kumar meena |
| Designation |
P.G resident |
| Affiliation |
Jln Medical College Ajmer |
| Address |
Emergency medicine department
Jln medical College
Ajmer, Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9711748413 |
| Fax |
|
| Email |
rajeevkumarmeenavmmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita jain |
| Designation |
Professor and head of Department |
| Affiliation |
Jln Medical College Ajmer |
| Address |
Emergency medicine department
Jln Medical College Ajmer
Rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita jain |
| Designation |
Professor and head of Department |
| Affiliation |
Jln Medical College Ajmer |
| Address |
Emergency medicine department
Jln Medical College Ajmer
Rajasthan
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Ajmer, Rajasthan, India – 305001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| 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 KAVITA JAIN |
Jawaharlal Nehru Medical College, Ajmer |
Department of Emergency Medicine, Jawaharlal Nehru Medical College, Ajmer, Rajasthan, India
Ajmer
RAJASTHAN |
9414006151
drkavitajain15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,JAWAHARLAL NEHRU MEDICAL COLLEGE AJMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with acute cerebrovascular accident including ischemic and hemorrhagic stroke. Presence of focal neurological deficit. Diagnosis confirmed by computed tomography or magnetic resonance imaging of brain. Patients presenting within twenty four hours of onset of symptoms. Age and sex matched healthy controls without history of cerebrovascular accident. |
|
| ExclusionCriteria |
| Details |
Patients with thrombocytopenia due to infective, hereditary or drug induced causes. Patients with known malignancy. Patients presenting after forty eight hours of onset of cerebrovascular accident. Subjects unable to provide informed consent and without a valid attendant. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess mean platelet volume and other platelet indices in patients with acute cerebrovascular accident and compare with age and sex matched controls. |
At baseline (at admission) and at 28 days follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of platelet indices with severity and clinical outcome of acute cerebrovascular accident. |
At admission and at 28 days |
|
|
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)
|
02/05/2026 |
| 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="3"
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
|
This is a hospital based prospective observational case control study conducted in a tertiary care center. The study includes patients presenting with acute cerebrovascular accident within twenty four hours of onset of symptoms and age and sex matched healthy controls. Platelet indices including mean platelet volume platelet distribution width platelet count and immature platelet fraction are assessed at the time of admission. Stroke severity is assessed using Modified Rankin Scale at admission and at twenty eight days. The study aims to evaluate the association of platelet indices with severity and clinical outcome of acute cerebrovascular accident. |