| 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
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Division of Pediatric pulmonology and Intensive Care, AIIMS |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |