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CTRI Number  CTRI/2012/05/002620 [Registered on: 01/05/2012] Trial Registered Retrospectively
Last Modified On: 16/06/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Data Collection project on patients with low platelet counts 
Scientific Title of Study   To Assess the incidence Risk Factors and impact on Transfusion requirements of Thrombocytopenia in Medical/surgical ICUs of Medanta-The Medicity (OST-Med) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
198/2012 version 1.1 dated 18th April,2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yatin Mehta 
Designation  Chairman,Critical Care and Anaesthesia 
Affiliation  Medanta-the Medicity 
Address  Medanta-The Medicity,Sec-38,Gurgaon.
Medanta-The Medicity,Sec-38,Gurgaon
Gurgaon
HARYANA
122001
India 
Phone  0124-4141414  
Fax  0124-4834468  
Email  yatin.mehta@medanta.org  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chitra Mehta 
Designation  Senior Consultant 
Affiliation  Medanta-the Medicity 
Address  Medanta-The Medicity,Sec-38,Gurgaon
Medanta-The Medicity,Sec-38,Gurgaon
Gurgaon
HARYANA
122001
India 
Phone  0124-4141414  
Fax  0124-4834468  
Email  mehtachitra@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chitra Mehta 
Designation  Senior Consultant 
Affiliation  Medanta-the Medicity 
Address  Medanta-The Medicity,Sec-38,Gurgaon
Medanta-The Medicity,Sec-38,Gurgaon
Gurgaon
HARYANA
122001
India 
Phone  0124-4141414  
Fax  0124-4834468  
Email  mehtachitra@hotmail.com  
 
Source of Monetary or Material Support  
Medanta-The medicity,Sec-38,Gurgaon,Haryana-122001 
 
Primary Sponsor  
Name  Medanta The Medicity 
Address  Medanta-The Medicity Sec-38,Gurgaon,Haryana-122001 
Type of Sponsor  Private hospital/clinic 
 
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 
Dr Chitra mehta  Medanta The Medicity,Department of Critical care and Anaesthesia,Mixed Surgical Units  Sector-38,Gurgaon,Haryana
Gurgaon
HARYANA 
9910395037

mehtachitra@otmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  post surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Above 18 years of age will be eligible for participation into the study 
 
ExclusionCriteria 
Details  a) Admitting Diagnosis strongly associated with thrombocytopenia
b) cardiac surgery
c) pregnancy
d) Patient with history of Platelet disorders
e) Hematologic Malignancy
f) Chemotherapy
g) IABP
h) Mechanical heart valve
i) Patient undergoing bypass surgery.
j) ICU stay 24 hours
k) Patient undergoing Liver transplant
l) Patient on CLD
M) Patient on splenectomy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Transfusion and Bleeding Episodes  6months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of thrombocytopenia, on duration of ICU Stay and ICU Mortality.  6 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="500" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/04/2012 
Date of Study Completion (India) 30/11/2012 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Mehta, Chitra, Joby v George, Yatin Mehta, M Tariq Ali, & Manish Kumar Singh. "Incidence and risk factors for thrombocytopenia in the intensive care units of a tertiary hospital in northern India." Southern African Journal of Critical Care [Online], 32.1 (2016): 28. Web. 16 Jun. 2021 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Prospective observational cohort study on thrombocytopenia is a observational study at Mixed Surgical/Medical Intyensive Care Units of Medanta-The Medicity which aims to assess the Incidence and identify the risk factors in Intensive care units which can be utilized  for further investigation/interventions for the purpose of decreasing Mortality and morbidity at ICU and thereby utilize for the optimization of Resources.

 
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