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CTRI Number  CTRI/2022/04/042168 [Registered on: 26/04/2022] Trial Registered Prospectively
Last Modified On: 10/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to assess the transfusion of leukoreduced blood units in thalassemia patients. 
Scientific Title of Study   A study to assess the transfusion efficacy of leukoreduced packed red blood cells prepared by two different methods in thalassemia major patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Adhikarimayum Arunkumari 
Designation  Junior Resident 
Affiliation  PGIMER, Chandigarh 
Address  Department of Transfusion Medicine, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9891215545  
Fax    
Email  drak48@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Jain 
Designation  Professor 
Affiliation  PGIMER, Chandigarh 
Address  Department of Transfusion Medicine, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009491  
Fax    
Email  ashishjain16@gmail.com  
 
Details of Contact Person
Public Query  
Name  Adhikarimayum Arunkumari 
Designation  Junior Resident 
Affiliation  PGIMER, Chandigarh 
Address  Department of Transfusion Medicine, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9891215545  
Fax    
Email  drak48@gmail.com  
 
Source of Monetary or Material Support  
PGIMER, Chandigarh 
 
Primary Sponsor  
Name  PGIMER Chandigarh 
Address  PGIMER, Chandigarh, Sector-12, 160012 
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 Adhikarimayum Arunkumari  PGIMER, Chandigarh  Department of Transfusion Medicine, 3rd level, Nehru Hospital, PGIMER, Sector-12, Chandigarh, 160012
Chandigarh
CHANDIGARH 		 9891215545

drak48@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional(Intramural) and Ethical Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D561||Beta thalassemia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Transfusion of NLPRBC   Transfusion(by intravenous route) of leukoreduced packed red blood cells prepared by a new method involving filtration of whole blood followed by separation into plasma and packed red blood cells in thalassemia major patients, at a dose of 1-2 units per patient at an interval of 2-3 weeks as per the requirement of the patient, for a total duration of 3 months. 
Comparator Agent  Transfusion of SLPRBC  Transfusion (by intravenous route)of standard leukoreduced packed red blood cells being prepared regularly in our institute by removal of buffy coat and plasma followed by leukofiltration in thalassemia patients, at a dose of 1-2 units per patient at an interval of 2-3 weeks as per the requirement of the patient, for a total duration of 3 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Adults
2. Transfusion-dependent thalassemia major patients
3. Receiving transfusions exclusively at the PGIMER, Chandigarh 
 
ExclusionCriteria 
Details  1. Minors (age<18 yrs)
2. Red cell autoantibodies in the patient
3. Massive splenomegaly
4. Any bleeding episode in the last 24 hours
5. Transfusion of any other blood product during the same episode
6. Pregnancy
7. Patients receiving washed red blood cells
8. Active ongoing fever or documented infection
9. Increased annual blood transfusion requirement (>200-220 mL/kg/year)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To detect a clinically significant difference of 0.3 g/dL rise in the hemoglobin increment between the two groups pf patients transfused with leukoreduced packed red blood cells prepared by the two different methods.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Effect on transfusion interval, number of units consumed   3 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/05/2022 
Date of Study Completion (India) 12/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drak48@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2110?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study will be a prospective, randomized, controlled trial conducted by the Department of Transfusion Medicine, Nehru Hospital, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh in collaboration with the Department of Pediatrics of our Institute which caters to the thalassemia day care patients. Sample size for the study is based on a minimum clinically important difference of 0.3g/dL in Hb increment and a standard deviation of 0.3 for improvement in Hb. After enrolment in the study, the patients will be randomized into two groups. Groups will be formed by listing the patients in the order of requisitions received and then randomization will be done using a block randomization method. Group I will receive SLPRBC prepared by the standard method in our institute of removal of buffy coat and plasma followed by leukoreduction. Group II will receive NLPRBC prepared by a new method involving leukoreduction of whole blood followed by separation into plasma and packed red blood cells. Both groups will receive their respective LPRBC units for a total period of three months. The patients will be followed up for a period of three months, at the end of which the outcomes will be observed in the form of the Hb increment after each transfusion episode, average transfusion interval, total number of LPRBC units transfused during the period, and the frequency of transfusion reactions. 

  
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