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CTRI Number  CTRI/2025/02/080752 [Registered on: 18/02/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Longitudinal Study 
Study Design  Other 
Public Title of Study   How Platelet Transfusions Affect Blood Counts in Dengue Patients 
Scientific Title of Study   Assessment of Platelet Indices and Leukocyte Count Alterations Pre- and Post-Platelet Transfusion in Hospitalized Dengue Patients 
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 Chandrasekar M 
Designation  Professor 
Affiliation  Galgotias University, Greater Noida, Uttar Pradesh 
Address  Department of Medical Laboratory Technology, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8015185002  
Fax    
Email  shekarmlt09@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mohd Afzal 
Designation  Research Scholar 
Affiliation  Galgotias University, Greater Noida, Uttar Pradesh 
Address  Department of Medical Laboratory Technology, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  7017190239  
Fax    
Email  mohd.23smas3050001@galgotiasuniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Chandrasekar M 
Designation  Professor 
Affiliation  Galgotias University, Greater Noida, Uttar Pradesh 
Address  Department of Medical Laboratory Technology, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8015185002  
Fax    
Email  shekarmlt09@hotmail.com  
 
Source of Monetary or Material Support  
Galgotias University, Plot No. 2, Sector 17-A, Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 203201, India 
 
Primary Sponsor  
Name  Dr Chandrasekar M 
Address  Galgotias University, Plot No. 2, Sector 17-A, Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida, Gautam Buddh Nagar, Uttar Pradesh 203201, India 
Type of Sponsor  Other [Self] 
 
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 Shivsharan Singh  Aarogyam Hospital & College, Department of Laboratory Medicine & Transfusion Medicine  Arogyam Hospital & Arogyam institute of paramedical & allied sciences, karondhi baghwanpur, roorkee Hardwar 247661
Hardwar
UTTARANCHAL 		 7017190239

shivsharan.singh@arogyam.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A91||Dengue hemorrhagic fever,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients diagnosis with dengue fever, Dengue Hemorrhagic Fever or Dengue Sock Syndrome as per WHO criteria
2. Patients who are hospitalized for dengue management in the tertiary care hospital.
3. Patients aged 18 years and above.
4. Patients who have received one platelet transfusion.
5. Patients or their legal guardians, who provide written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Other Infections like malaria, typhoid that could affect hematological parameters done by Fever profile.
2. Patients with pre-existing chronic hematological disorders (e.g., leukemia, aplastic anemia) that confound results.
3. Below 18 years old age individuals due to the distinct physiological differences between children and adults.
4. Patients on immunosuppressive therapy or chemotherapy, as these treatments can affect leukocyte counts and platelet indices.
5. Pregnant women, due to the physiological changes in hematological parameters during pregnancy.
6. Patients with severe chronic diseases (e.g., end-stage renal disease, severe liver cirrhosis) that could impact hematological parameters and recovery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is to evaluate the changes in platelet indices (Platelet Count [PC], Mean Platelet Volume [MPV], Platelet Distribution Width [PDW], Plateletcrit [PCT], and Platelet-Large Cell Ratio [P-LCR]) before and after platelet transfusion in hospitalized dengue patients.  1 Year 
 
Secondary Outcome  
Outcome  TimePoints 
1. Analyzing changes in leukocyte count and platelet-to-WBC ratio (PWR) pre- and post-transfusion and their association with recovery outcomes.
2. Identifying morphological changes in white blood cells (e.g., hypersegmented neutrophils, reactive lymphocytes, toxic granules) as potential predictors of hematological response and complications following platelet transfusion.
3. Comparing the efficacy of manual and automated methods in assessing platelet and leukocyte parameters, including morphological changes.
4. Investigating the relationship between PWR changes and recovery speed or hospital stay duration.
 		 1 Year 
 
Target Sample Size   Total Sample Size="121"
Sample Size from India="121" 
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)   03/03/2025 
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 study titled "Assessment of Platelet Indices and Leukocyte Count Alterations Pre- and Post-Platelet Transfusion in Hospitalized Dengue Patients" investigates the hematological changes associated with platelet transfusion in dengue patients. Dengue, a mosquito-borne viral infection, often leads to severe thrombocytopenia (low platelet count), necessitating platelet transfusions to manage bleeding risks.

This research focuses on evaluating platelet indices (platelet count, mean platelet volume, platelet distribution width, and plateletcrit) and leukocyte count alterations before and after platelet transfusion. By analyzing these parameters, the study aims to determine the efficacy and physiological response to transfusion therapy in dengue patients.

The study employs both manual and automated methods for measuring platelet and leukocyte parameters, including WBC morphology. It aims to determine the effectiveness of these methods in capturing hematological changes and resolving challenges like the inability of automated analyzers to accurately count giant platelets. Morphological changes in WBCs, such as hypersegmented neutrophils, reactive lymphocytes, and toxic granules, will also be analyzed to understand their potential as predictors of hematological response and transfusion-related complications.  An increase in the platelet-to-WBC ratio (PWR) will correlate with faster recovery and shorter hospital stays.

 
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