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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
post surgery, |
|
Intervention / Comparator Agent
|
|
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. |