Tuesday, September 16, 2025 9/16/2025

Transfusion and Organ Dysfunction in Pediatric Septic Shock (TROPICS) study

Award Number: R01HL157208
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/20/2022
PERIOD OF PERFORMANCE END DATE: 02/28/2027

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Transfusion and Organ Dysfunction in Pediatric Septic Shock (TROPICS) study - Abstract Worldwide, nearly 3 million children die each year from sepsis. Red blood cells (RBC) are transfused in ~50% of children with septic shock, with the intent to enhance oxygen delivery, help resolve shock, and prevent organ dysfunction. However, RBC transfusion has repeatedly been associated with adverse outcomes in critical illness, suggesting harm. For most children with septic shock we lack data to identify who should or should not be transfused. Interventional trials and RBC transfusion guidelines have used hemoglobin concentration alone to inform RBC transfusion decisions. However, this is likely not the best way to decide when to transfuse RBCs to a patient with shock. Our preliminary data in septic children suggest that hemodynamic measures better identify children who might benefit from RBC transfusion and that children with severe immune suppression may be at greater risks of transfusion-related harm. Lastly, our data show that RBC transfusion effects likely differ based on RBC unit collection, storage, and processing methods, and resultant quantities of soluble mediators. Together, these data support our hypothesis that physiologic and blood product factors will predict when children with septic shock will benefit from, or be harmed by, RBC transfusion. The overall goal of our research program is to develop a personalized-medicine approach to RBC transfusion in children with septic shock. Our objective for this proposal is to build decision support tools that can be used in future clinical trials to identify when children with septic shock should or should not be transfused with RBCs. Our proposal uses robust machine learning techniques that are designed to use a very large number of dynamic variables to define personalized treatment decisions that maximize clinical outcomes. With these methods, and an agnostic, data-driven approach, the resultant decision rules will be free of clinician bias and can consider a much wider array of clinical parameters than have traditionally been used in transfusion trials. We will conduct a multicenter prospective observational study of 660 children with septic shock to accomplish the following specific aims: Aim 1: Determine which clinical, hemodynamic, and blood product-specific factors should drive RBC transfusion decision-making in children with septic shock. Using data from the electronic medical record, we will use outcome-weighted learning to build dynamic transfusion algorithms to minimize predicted daily organ dysfunction (PELOD2 scores). Aim 2: Identify immune phenotypes that predict differential response to RBC transfusion in children with septic shock. We will collect serial blood samples from subjects to measure a validated panel of inflammatory and immune function biomarkers and test the hypothesis that outcomes related to RBC transfusion will differ based on pre-transfusion levels of biomarkers of inflammation and/or immune suppression. We expect our data to transform the design of interventional trials of data-driven RBC transfusion algorithms to shift the transfusion paradigm away from hemoglobin-based strategies and improve outcomes for critically ill septic children.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $683,143 )
2025	2025	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Blood Diseases and Resources Research	000	4	1/27/2025	NON-COMPETING CONTINUATION	$614,829
2025	2025	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Blood Diseases and Resources Research	001	4	7/31/2025	NON-COMPETING CONTINUATION	$68,314
														Subtotal = $683,143

Issue Date FY: 2024 ( Subtotal = $680,899 )
2024	2024	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Blood Diseases and Resources Research	001	3	6/21/2024	NON-COMPETING CONTINUATION	$55,584
2024	2024	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Blood Diseases and Resources Research	000	3	3/13/2024	NON-COMPETING CONTINUATION	$625,315
														Subtotal = $680,899

Issue Date FY: 2023 ( Subtotal = $712,739 )
2023	2023	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Blood Diseases and Resources Research	000	2	2/17/2023	NON-COMPETING CONTINUATION	$712,739
														Subtotal = $712,739

Issue Date FY: 2022 ( Subtotal = $865,679 )
2022	2022	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Blood Diseases and Resources Research	000	1	3/16/2022	NEW	$865,679
														Subtotal = $865,679

Grand Total All Awards = $2,942,460

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Transfusion and Organ Dysfunction in Pediatric Septic Shock (TROPICS) study

Award Number: R01HL157208

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 03/20/2022

PERIOD OF PERFORMANCE END DATE: 02/28/2027

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