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CTRI Number  CTRI/2026/01/101336 [Registered on: 16/01/2026] Trial Registered Prospectively
Last Modified On: 16/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Comparing two transfusion thresholds ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   DO CHILDREN WITH SEPTIC SHOCK HAVE GREATER TRANSFUSION REQUIREMENTS? 
Scientific Title of Study   Liberal VS Restrictive TRansfusion thresholds In Pediatric Patients with Septic Shock: A randomised controlled trial 
Trial Acronym  TRIPSS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samprati Agrawal  
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences  
Address  Division of Pediatric Pulmonology and Intensive Care, Department of Pediatrics, AIIMS
Office , Department of Pediatrics, AIIMS
South
DELHI
110029
India 
Phone  8826976182  
Fax    
Email  samprati.agrawal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jhuma Sankar 
Designation  Professor  
Affiliation  All India Institute of Medical Sciences 
Address  Room 839, Department of Pediatrics, AIIMS

South
DELHI
110029
India 
Phone  9818399864  
Fax    
Email  jhumaji@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jhuma Sankar 
Designation  Professor  
Affiliation  All India Institute of Medical Sciences 
Address  Room 839, Department of Pediatrics, AIIMS

South
DELHI
110029
India 
Phone  9818399864  
Fax    
Email  jhumaji@gmail.com  
 
Source of Monetary or Material Support  
AIIMS 
 
Primary Sponsor  
Name  AIIMS  
Address  Division of Pediatric pulmonology and Intensive Care, AIIMS 
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 Samprati Agrawal  AIIMS New Delhi  Room no 839, 8th floor, Mother and child Block, Department of Pediatrics, AIIMS New Delhi
South
DELHI 
8826976182

samprati.agrawal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I958||Other hypotension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Liberal transfusion strategy  We will transfuse children whose haemoglobin is less than or equal to 9 gm per dL.  
Comparator Agent  Restrictive transfusion strategy   We will transfuse packed RBCs if the haemoglobin is less than equal to 7 gm/dL.  
 
Inclusion Criteria  
Age From  28.00 Day(s)
Age To  17.00 Year(s)
Gender  Both 
Details  Children admitted to PICU
Aged 28 days to 17 years
Meeting Phoenix criteria for septic shock
Hemoglobin less than 9 g per dl
 
 
ExclusionCriteria 
Details  Patients with malignancies
Patients with hemolytic anemias
Patients with a hemoglobin level less than 5 g per dl
Patients with cyanotic Congenital Heart Disease
Patients with Chronic Kidney Disease
Patients with an anticipated mortality in the next 24 hours post randomisation
Patients who were administered PRBCs during this admission before the child developed shock
Life-threatening bleed
Need for a surgical procedure requiring higher hemoglobin levels
Dengue Shock
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The proportion of patients with shock resolution at 24 hours post-randomisation  The proportion of patients with shock resolution at 24 hours post-randomisation 
 
Secondary Outcome  
Outcome  TimePoints 
The proportion of patients with shock resolution during ICU stay  During ICU stay 
To compare the time to shock resolution  TIme duration from onset of shock to resolution 
All-cause mortality at 28 days post-randomisation  At 28 day post randomisation 
Number of patients in both the groups requiring vasoactive drugs—within the first 7 days following enrollment  7 days from randomisation 
The incidence of Healthcare-Associated Infections (HAI)  During ICU stay 
Change in Pediatric Logistic Organ Dysfunction Score (PELOD) from randomisation to Change in Pediatric Logistic Organ Dysfunction Score (PELOD) from randomisation to 24 hrs, 72 hours, and 7 days post randomisation  At 24 hrs, 72 hrs and 7 days post randomisation 
The incidence of transfusion-related complications between the groups  Upto 28 days of transfusion 
The length of PICU stay  Throughout PICU stay 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   31/01/2026 
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="2"
Months="0"
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 optimal threshold for PRBC transfusion remains a clinically relevant question in contemporary pediatric critical care. Very few studies have investigated the optimal transfusion thresholds in patients with sepsis, and even fewer in patients with septic shock. Current recommendations by the Surviving Sepsis Campaign, published in 2020, recommend against transfusing hemodynamically stabilized children with septic shock with a hemoglobin of more than  equal to 7 g/dL; however, specific recommendations for unstable septic shock patients remain limited due to a lack of evidence.6  The Pediatric Critical Care Transfusion and Anemia Expertise Initiative TAXI has provided nuanced recommendations for hemodynamically unstable and stable children. For hemodynamically stable children, they recommend against transfusing at a hemoglobin of more than 7 g/dl, while acknowledging that for unstable children, a higher hemoglobin may be beneficial, and that a lack of evidence precludes them from recommending thresholds in such children.

There is thus a pressing need for further studies that help determine optimal transfusion thresholds in critically ill children with septic shock and hemodynamic instability, preventing undue exposure to blood products and infections while also optimising oxygen delivery in a background of compromised perfusion. We, thus plan to conduct this study to determine whether a restrictive or a liberal transfusion threshold is optimal for transfusion in patients with septic shock.  

 
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