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CTRI Number  CTRI/2024/02/063089 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 22/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   "Clinical relevance of immature platelet fraction in thrombocytopenia and its role in differentiating bone marrow suppression and destruction of platelets" 
Scientific Title of Study   Clinical relevance of immature platelet fraction in thrombocytopenia and its role in differentiating bone marrow suppression and destruction of platelets 
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 SOUMYA MITRUKA 
Designation  MD Pathology(Junior resident) 
Affiliation  Kasturba Medical College MAHE Manipal 
Address  Department of pathology 2nd floor Basic Sciences building Kasturba Medical College Madhav Nagar Manipal Udupi 576104

Udupi
KARNATAKA
576104
India 
Phone  8287920677  
Fax    
Email  soumya.mitruka@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SUSHMA BELURKAR 
Designation  Additional Professor (Pathology) 
Affiliation  Kasturba Medical College MAHE Manipal 
Address  Department of pathology 2nd floor Basic Sciences building Kasturba Medical College Madhav Nagar Manipal Udupi 576104

Udupi
KARNATAKA
576104
India 
Phone  8287920677  
Fax    
Email  sushma.b@manipal.edu  
 
Details of Contact Person
Public Query  
Name  DR SOUMYA MITRUKA 
Designation  MD Pathology (Junior resident) 
Affiliation  Kasturba Medical College MAHE Manipal 
Address  Department of pathology 2nd floor Basic Sciences building Kasturba Medical College Madhav Nagar Manipal Udupi 576104

Udupi
KARNATAKA
576104
India 
Phone  8287920677  
Fax    
Email  soumya.mitruka@gmail.com  
 
Source of Monetary or Material Support  
PG Research Grant Kasturba Medical College, MAHE, Manipal, Karnataka 
 
Primary Sponsor  
Name  Kasturba Medical College MAHE Manipal RESEARCH GRANT 
Address  Department of Pathology 2nd floor Basic Sciences building Kasturba Medical College Madhav Nagar Manipal Udupi 576104 
Type of Sponsor  Research institution and hospital 
 
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 Soumya Mitruka  Kasturba Medical College MAHE Manipal  Department of Pathology 2nd floor Basic Sciences building Madhav Nagar Manipal Udupi 576104
Udupi
KARNATAKA 		 8287920677

soumya.mitruka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE - 2 (STUDENT RESEARCH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients visiting for health check purposes 
Patients  (1) ICD-10 Condition: D61||Other aplastic anemias and other bone marrow failure syndromes, (2) ICD-10 Condition: D69||Purpura and other hemorrhagic conditions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All adults (18years and above) having thrombocytopenia with a definitive diagnosis 
 
ExclusionCriteria 
Details  1) All pediatric patients
2) Samples with platelet clumps
3) Patients on drug therapy / chemotherapy 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
• To determine immature platelet fraction in patients with thrombocytopenia using automated hematology analyzer (SYSMEX XN-1500)

• To determine normal reference range of immature platelet fraction in healthy controls 		 11 months (1 march 2023 to 28 february 2024) 
 
Secondary Outcome  
Outcome  TimePoints 
To determine whether immature platelet fraction can be used reliably to distinguish between hypo-productive thrombocytopenia and hyper-destructive thrombocytopenia  11 months (1 march 2023 to 28 february 2024) 
 
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)   29/03/2024 
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="0"
Months="11"
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   Thrombocytopenia is a condition with low platelet counts resulting from decrease in bone marrow production of platelets or increase in platelet destruction. The reticulated platelets were discovered in 1969 and many research studies gave evidence of it being sensitive marker of thrombopoiesis. Earlier it was estimated by fluorescence flow cytometry but since 1990’s a new method is introduced to estimate reticulated platelets and is termed as automated method. Various platelet parameters obtained by automated hematology analyzer are Mean platelet volume, plateletcrit, platelet distribution width, platelet large cell ratio and immature platelet fraction. Immature platelet fraction is one of the component of automated method used to assess the thrombopoietic activity in bone marrow. Rinder et al. showed that an increased percentage of reticulated platelets indicated in thrombocytopenia correlated well with increased megakaryocytic proliferation in bone marrow whereas decrease in percentage of reticulated platelets indicated decrease in number of bone marrow megakaryocytes. Zeigler et al. reported that large platelets were seen in individuals with thrombocytopenia due to Immune thrombocytopenic purpura whereas platelet size was normal in patients with thrombocytopenia due to bone marrow aphasia, hypersplenism and thrombotic thrombocytopenic purpura with a normal platelet count. Briggs et al. in 2004 published a study done on SYSMEX XE stated, increase in immature platelet fraction was seen in individuals with immune thrombocytopenic purpura (mean 22.3%; range 9.2-33.1%) and thrombotic thrombocytopenic purpura (mean 17.2%; range 11.2-30.9%). The normal range was taken as 1.1-8.1%. They also noted that as the platelet count increases the immature platelet fraction percentage falls. Abe et al. showed that the immature platelet fraction was significantly higher in patients with immune thrombocytopenic purpura and significantly lower in patients during the nadir phase post chemotherapy and in normal range in incomplete immune thrombocytopenic purpura patients and those with aplastic anemia. Linden et al. showed that immature platelet fraction could be used as a predictor of platelet recovery within 2 days using cut-off of 5.3% in patients receiving autologous stem cell transplantation. 
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