| CTRI Number |
CTRI/2024/07/070916 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
14/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding how blood components and its related factors help to predict outcome in sick children |
|
Scientific Title of Study
|
Platelet indices as a prognostic factors in critically ill children |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranga Sai Vineeth |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Paediatrics, Kasturba Medical College, MAHE, Manipal, Udupi,
Karnataka
Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
7032078258 |
| Fax |
|
| Email |
ranga.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrikiran A Hebbar |
| Designation |
MD Paediatrics, Professor and HOU, Department of Paediatrics , KMC Manipal |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Paediatrics, Kasturba Medical College, MAHE, Manipal, Udupi,
Karnataka
Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9448177671 |
| Fax |
|
| Email |
shrikiran.a@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen C Samuel |
| Designation |
MD Paediatrics, Assistant Professor, Department of Paediatrics, KMC Manipal |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Paediatrics, Kasturba Medical College, MAHE, Manipal, Udupi,
Karnataka
Kasturba Medical College, MAHE, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India
Udupi
KARNATAKA
576104
India |
| Phone |
9633955566 |
| Fax |
|
| Email |
Praveen.samuel@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal, Udupi,576104 ,Karnataka, India |
|
|
Primary Sponsor
|
| Name |
KASTURBA MEDICAL COLLEGE MANIPAL |
| Address |
DEPARTMENT OD PAEDIATRICS, KASTURBA MEDICAL COLLEGE, MAHE, MANIPAL, UDUPI, KARNATAKA,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 |
| Dr Ranga Sai Vineeth |
Kasturba Medical College and Hospita |
2nd floor, PICU, Women and
Children block, Department of
Paediatrics, Kasturba Medical
College, Madharv Nagar,
Manipal, 576104
Udupi
KARNATAKA
Udupi
KARNATAKA |
7032078258
ranga.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R791||Abnormal coagulation profile, (2) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All the patients admitted in the PICU from the age group of 1 month to 18 years in Kasturba medical college and Hospital, Manipal meeting criteria for critically ill child. |
|
| ExclusionCriteria |
| Details |
Children with haematological diseases (leukemias, lymphoma ,inherited bone marrow disorders, idiopathic thrombocytopenia purpura ), Children on radiotherapy or chemotherapy , Children on anti platelet therapy (Eg: Aspirin ,clopidogrel) , Recent history of any platelet transfusion, History of
splenectomy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict the prognosis of critically ill children with the help of platelet indices and to compare the platelet indices and platelet ratios with severity of illnesses |
Within 24 hours of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
28/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Children of age >1 month and <18 years admitted to the PICU, KMC, Manipal will be taken up for the study, history will be noted (present history,
past history, family history)& general examination ( Anthropometry, vitals and head
to toe examination, systemic examinations) will be noted. Samples sent for platelet indices on the day admission in the PICU are noted . At admission ‘Modified PRISM 3’ score will be calculated. Platelet indices were measured using an automated blood analyser, Sysmex Automated Hematology System . Platelet count , MPV , PDW , and PCT are compared with the standard normal values . The standard values for PCT , PDW and PCT are 7.5 -11 fl ,11-18% and 0.15-0.5 % respectively for study purpose . In severe prognosis of the patient repeat sample is noticed. Data will be analyzed by using statistical software SPSS version 20.0. Aim To evaluate the utility of platelet indices as
prognostic indicator in critically ill children |