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CTRI Number  CTRI/2019/08/020831 [Registered on: 21/08/2019] Trial Registered Prospectively
Last Modified On: 24/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of infection risk in trauma patients transfused with leukoreduced vs non-leukoreduced blood 
Scientific Title of Study   A Randomized Control Trial for evaluation of effects of leukoreduced blood transfusion on infection risk in severely injured trauma patient 
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Chaurasia 
Designation  Assistant professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 215, Jai Prakash Narayan Apex Trauma center, AIIMS. New Delhi
Room no. 4, Main Blood Bank, Department of Transfusion Medicine, AIIMS. New Delhi
South
DELHI
110029
India 
Phone  9560345917  
Fax    
Email  drrahulchaurasia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul Chaurasia 
Designation  Assistant professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 215, Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi
Room no. 4, Main Blood Bank, Department of Transfusion Medicine, AIIMS. New Delhi
South
DELHI
110029
India 
Phone  9560345917  
Fax    
Email  drrahulchaurasia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Chaurasia 
Designation  Assistant professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room no. 215, Jai Prakash Narayan Apex Trauma Center, AIIMS, New Delhi
Room no. 4, Main Blood Bank, Department of Transfusion Medicine, AIIMS. New Delhi
South
DELHI
110029
India 
Phone  9560345917  
Fax    
Email  drrahulchaurasia@gmail.com  
 
Source of Monetary or Material Support  
(Intramural project) Research section, AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS 
Address  Ansari Nagar, New Delhi 
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 Rahul Chaurasia  JPNATC, AIIMS  Room No. 214, Blood Bank, Dept of Transfusion Medicine
South
DELHI 		 9560345917

drrahulchaurasia@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC. AIIMS  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Leukoreduced blood component transfusion  Blood components will be leucofiltered during processing and storage using commercially available leukofilter for blood components 
Comparator Agent  standard blood component  blood components will be processed and stored as the current standards/operating procedures 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  all patients above 18 years of age receiving RBC transfusion within 24 hours of admission.  
 
ExclusionCriteria 
Details  1) Patients with an anticipated survival of less than 48 hours
2) Isolated head injury patients
3) Received blood transfusion elsewhere
4) Presence of active infection
5) Pregnant females and jail inmates will be not eligible for randomization.
6) Patient with Rh(D) negative groups
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome will include development of all hospital acquired infections [urinary tract infections (UTI), bloodstream infections (BSI), pneumonia (PNEU), ventilator-associated infections (VAE), and surgical site infections (SSI)] as defined by CDC/NHSN surveillance definition   Till the time of discharge or hospital death whichever is earlier 
 
Secondary Outcome  
Outcome  TimePoints 
Monitoring of the quantitative levels of sTREM and procalcitonin measured in all patients.
Proportion of patient showing values above cut-off limit shall be considered as having infection 		 Till the time of discharge or death whichever is earlier 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/09/2019 
Date of Study Completion (India) 01/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/04/2024 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Blood transfusion plays an important role in the management of trauma patients. Transfusion of blood components leads to introduction of immune components such as white blood cells, antibodies and cytokines responsible for Immune alterations in the recipients. In severely injured patients a dysregulated immune response due to the trauma itself along with large requirement of blood transfusion over shorter time periods making them more susceptible to the immunomodulatory effects of blood transfusion. Often resulting in complications like increased risk of infections, length of stay, pulmonary morbidity, postinjury MOF (multiple organ failure) and mortality in these group of patient. Leukoreduction of the blood components before transfusion has been advocated to decrease the effect of immunomodulation by eliminating direct actions of the leukocytes as well as the accumulation of leukocyte-derived inflammatory mediators.

In this study we will compare the incidence of hospital acquired infections in severely injured trauma patients transfused with leukoreduced (LR) vs non-leukoreduced (NLR) blood components. We will also measure outcomes clinically and quantitative changes in biomarkers/microbiological indicators bacterial infections.

 
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