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CTRI Number  CTRI/2026/02/102776 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of under-collected and standard blood units for transfusion: A Randomized controlled study  
Scientific Title of Study   The quality of under collected blood units for transfusion: A Randomized control study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
2024-20-PGTH-9 Version 1 dt 14-02-2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amulya Kishan 
Designation  MD Student 
Affiliation  A.I.I.M.S, Raebareli 
Address  Department of Transfusion Medicine, Basement, A.I.I.M.S, Raebareli

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  8862932845  
Fax    
Email  kishanamulya949@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Trupti Lokhande 
Designation  Assistant Professor and Guide 
Affiliation  A.I.I.M.S, Raebareli 
Address  Room no 441,Fourth floor, Department of Transfusion Medicine, A.I.I.M.S, Raebareli

Rae Bareli
UTTAR PRADESH
229405
India 
Phone  7877163088  
Fax    
Email  drtrupti.lokhande02@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Trupti Lokhande 
Designation  Assistant Professor and Guide 
Affiliation  A.I.I.M.S, Raebareli 
Address  Room no 441,Fourth floor, Department of Transfusion Medicine, A.I.I.M.S, Raebareli


UTTAR PRADESH
229405
India 
Phone  7877163088  
Fax    
Email  drtrupti.lokhande02@gmail.com  
 
Source of Monetary or Material Support  
A.I.I.M.S., Munshiganj, Raebareli 229405 
 
Primary Sponsor  
Name  Dr Amulya Kishan 
Address  Dept of Transfusion Medicine, A.I.I.M.S., Munshiganj, Raebareli  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Trupti Lokhande   Room no. 441,Dept of Transfusion Medicine, A.I.I.M.S., Munshiganj, Raebareli  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dnyaneshwar Patale  A.I.I.M.S ,Raebareli  Dept of Transfusion Medicine
Rae Bareli
UTTAR PRADESH 		 8850112287

dnyaneshwar.patale@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bioethics cell, All India Institute of Medical Sciences,Raebareli, Uttar Pradesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D649||Anemia, unspecified, (2) ICD-10 Condition: D638||Anemia in other chronic diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low volume packed red blood cells   One unit of Low volume packed red blood cells at a time  
Comparator Agent  Standard volume packed red blood cells  One unit of standard volume packed red blood cells at a time 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Adult patient with age more than 18 yrs admitted to Medicine Department, AIIMS Raebareli
2.Indication for PRBC transfusion: Patient with chronic severe anaemia with hemoglobin less than 7gm/dl.
 
 
ExclusionCriteria 
Details  1.Patients with age less than 18 yrs
2.Patients with hemolytic anemia.
3.Patients with more than one unit PRBC transfusion at a time.
4.Patients with chronic severe anemia with hemoglobin more than 7gm/dl.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Hemoglobin (g/dL) of patient  24 hrs post-transfusion 
 
Secondary Outcome  
Outcome  TimePoints 
pH of PRBC  Day 0,7,14,21,28,35,42 or at time of issue if earlier than scheduled time point 
Hemolysis of PRBC  Day 0,7,14,21,28,35,42 or at time of issue if earlier than scheduled time point 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   02/03/2026 
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="9"
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  

Packed red blood cell (PRBC) transfusion is a commonly used treatment for patients with anemia. During routine blood donation, under-collection of whole blood may occur because of donor reactions or technical issues, resulting in under-collected blood units. Although current guidelines allow the use of such units for transfusion, limited evidence is available regarding their quality during storage and their effectiveness in improving hemoglobin levels after transfusion.

This randomized controlled trial aims to evaluate the quality of PRBCs prepared from under-collected whole blood units by assessing changes in pH and hemolysis during storage, and to compare post-transfusion hemoglobin increment in anemic adult patients receiving under-collected PRBC units versus standard-volume PRBC units. The findings of this study may help optimize transfusion practices and improve utilization of under-collected blood units without compromising patient safety.

 
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