CTRI

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CTRI Number

CTRI/2023/12/060625 [Registered on: 21/12/2023] Trial Registered Prospectively

Last Modified On:

20/12/2023

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Case Control Study

Study Design

Other

Public Title of Study

Immature platelet fraction in children with severe thrombocytopenia

Scientific Title of Study

To Study the role of immature platelet fraction in children with severe thrombocytopenia

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 Aishwarya N
Designation	Junior resident Department of Paediatrics
Affiliation	Kasturba Medical college, Manipal, MAHE
Address	Department of pediatrics Kasturba medical college Manipal Udupi KARNATAKA 576104 India
Phone	7358612250
Fax
Email	aishwarya1963@gmail.com

Details of Contact Person
Scientific Query

Name	Dr SANDESH KINI B
Designation	ASSOCIATE PROFESSOR
Affiliation	Kasturba Medical college, Manipal, MAHE
Address	Department of pediatrics Kasturba medical college Manipal Udupi KARNATAKA 576104 India
Phone	9731149519
Fax
Email	sandesh.kini@manipal.edu

Details of Contact Person
Public Query

Name	Dr Aishwarya N
Designation	Junior resident Department of Paediatrics
Affiliation	Kasturba Medical college, Manipal, MAHE
Address	Department of pediatrics Kasturba medical college Manipal Udupi KARNATAKA 576104 India
Phone	7358612250
Fax
Email	aishwarya1963@gmail.com

Source of Monetary or Material Support

Department of pediatrics kasturba medical college manipal

Primary Sponsor

Name	MANIPAL ACADEMY OF HIGHER EDUCATION
Address	Department of pediatrics,kasturba medical college,manipal
Type of Sponsor	Private medical college

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 N AISHWARYA CHEZHIAN	KMC MANIPAL	DEPARTMENT OF PEDIATRICS AND DEPARTMENT OF HEMATOLOGY AND ONCOLOGY WOMEN AND CHILD BLOCK 2ND FLOOR AND GROUND FLOOR KMC MANIPAL Udupi KARNATAKA	7358612250 aishwarya1963@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: D50-D89\|\|Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	nil	nil
Intervention	NIL	NIL

Inclusion Criteria

Age From	1.00 Month(s)
Age To	18.00 Year(s)
Gender	Both
Details	Cases: Children from 1month to 18years of age with severe thrombocytopenia having Platelet count less than 1,00,000 per microlitre. Control: Controls: Children from 1month to 18years of age with platelet counts within normal limits 1,50,000/microlitre to 4,50,000/microlitre

ExclusionCriteria

Details

Children diagnosed with haematological malignancies (leukaemia, lymphoma)
and currently on anti-cancer drugs.
Children previously diagnosed of idiopathic thrombocytopenic purpura,
thrombotic thrombocytopenic purpura, aplastic anemia on disease specific
treatment.
Children who had received platelet transfusion in the past 1 month

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
The role of immature platelet fraction in severe thrombocytopenia and its range in paediatrics population in different aetiologies will be analysed at the end of the study after 18 months	18 MONTHS

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="300"
Sample Size from India="300"
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)

31/12/2023

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 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

The assessment of bone marrow thrombopoietic activity in patients with thrombocytopenia is necessary to achieve an accurate diagnosis and administer effective Treatment.Immature platelets can be useful marker of thrombopoietic activity.They represent the most recently produced platelets released into the circulation by regenerated bone marrow megakaryocytes.The number of circulating immature platelets reflects the rate of thrombopoiesis and bone marrow function and, as such, may be useful in the determination of thrombocytopenic etiology.A study done in UK in the year 2019 showed the IPF was significantly higher in cases of increased platelet consumption compared with controls. Another study in Republic of Korea between January 2016 to July 2018 showed IPF is higher in hyper destructive thrombocytopenia compared to control group. In this study the blood sample collected during admission for evaluation purpose will be used for estimation of immature platelet fraction in all the children included in the study. The sample will be processed at the earliest and processed by flowcytometry using optical fluorescence method. The data collected at the end of the study will be used to study the role of immature platelet fraction in different aetiologies of severe thrombocytopenia.