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CTRI Number  CTRI/2022/08/044653 [Registered on: 04/08/2022] Trial Registered Prospectively
Last Modified On: 20/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Role of blood Platelet values in predicting severity of a brain stroke patient 
Scientific Title of Study   Study of Platelet indices in patients of Acute Ischemic Stroke. (AIS) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sravanth Gandavarapu 
Designation  Resident 
Affiliation  D.Y. Patil School of Medicine, Navi Mumbai 
Address  1002, B-wing, Balaji Towers, Sector-22, Nerul, Navi Mumbai.
School of Medicine, Dr. D. Y. Patil Hospital and Deemed to be university, Nerul, Navi Mumbai, Thane
Thane
MAHARASHTRA
400706
India 
Phone  8790014977  
Fax    
Email  1516sravanth@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sravanth Gandavarapu 
Designation  Resident 
Affiliation  D.Y. Patil School of Medicine, Navi Mumbai 
Address  1002, B-wing, Balaji Towers, Sector-22, Nerul, Navi Mumbai.
School of Medicine, Dr. D. Y. Patil Hospital and Deemed to be university, Nerul, Navi Mumbai, Thane
Thane
MAHARASHTRA
400706
India 
Phone  8790014977  
Fax    
Email  1516sravanth@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Archana Bhate  
Designation  Professor 
Affiliation  Dr. D. Y. Patil Hospital and Deemed to be University 
Address  Department of Medicine, School of Medicine, Dr. D. Y. Patil Hospital and Deemed to be university, Nerul, Navi Mumbai, Thane
Department of Medicine,school of medicine, Dr. D. Y. Patil Hospital and Deemed to be university, Nerul, Navi Mumbai, Thane
Thane
MAHARASHTRA
400706
India 
Phone  09821366812  
Fax    
Email  Archbhate@gmail.com  
 
Source of Monetary or Material Support  
School of Medicine, D.Y. Patil Deemed to be University 
 
Primary Sponsor  
Name  Sravanth Gandavarapu 
Address  Department of Medicine, School of Medicine, Dr. D. Y. Patil Hospital and Deemed to be University, Sector-5 , Nerul, Navi Mumbai 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sravanth Gandavarapu  Dr. D. Y. Patil deemed to be University  Floor 3,Department of Medicine, School of Medicine, Dr.D.Y.Patil Hospital and deemed to be University, Nerul, Navi Mumbai
Thane
MAHARASHTRA 		 8790014977

1516sravanth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D758||Other specified diseases of bloodand blood-forming organs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Any Patient who presents with Acute Ishemic Stroke which is diagnosed by Radiological method. 
 
ExclusionCriteria 
Details  Pregnant women
Pediatric Population
AIDS
Cancer
Any Bone Marrow Disorder
Sepsis 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean pletelet volume and pletelet distribution width are assesed to compare the severity of Acute ishemic strokes  2-3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To know the Role of Platelet Indices in predicting severity of Acute Ischemic Stroke  4 months to 6months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/08/2022 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  DATA WILL BE UPLOADED IN CTRI AND WILL BE AVAILABLE IF PROPOSED TO EMAIL: 1516SRAVANTH@GMAIL.COM

  6. For how long will this data be available start date provided 25-12-2022 and end date provided 25-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The Present study is the clinical observational study for completion under Dr. D. Y. Patil deemed to be University
Total Duration of Trial is 1 year
Title: Study of Platelet Indices in patients of Acute Ischemic Stroke.
Study Group: Sample Size 90
Study Centre: School Of Medicine, Dr. D. Y. Patil deemed to be University and Hospital, Nerul, Navi Mumbai.
PG Scholar : Dr. Sravanth Gandavarapu
Guide: Dr. Archana Bhate.
 
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