Trial · NCT01977547

Age of Blood in Children in Pediatric Intensive Care Units

NCT01977547, Phase 3, Completed, Washington University School of Medicine; results first posted 2021-04-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Age of Blood in Children in Pediatric Intensive Care Units. Trials, record NCT01977547. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01977547

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Age of Blood in Children in Pediatric Intensive Care Units
NCT number: NCT01977547
Status: Completed
Phases: Phase 3
Enrollment: 1,538 participants, actual
Lead sponsor: Washington University School of Medicine
Conditions: Anemia
Interventions: Short storage RBC age
First posted: 2013-11-06
Last updated: 2021-04-29
Results first posted: 2021-04-29

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)	28 days after randomization	The primary outcome measure of this RCT is NPMODS defined as the proportion of patients who die during the 28 days after randomization or who develop NPMODS. For patients with no organ dysfunction at randomization, New MODS is the development of ≥ 2 concurrent organ dysfunctions during the 28 days after randomization. For patients with 1 organ dysfunction at randomization, New MODS is the development of at least 1 other concurrent organ dysfunction after randomization. Patients with MODS (ie concurrent dysfunction of ≥ 2 organ systems) at randomization can develop Progressive MODS defined as development of at least 1 additional concurrent organ dysfunction at during the 28 days after randomization. All deaths will be considered Progressive MODS. NPMODS will be monitored up to 28 days or ICU discharge because it is almost never observed beyond this time in children.
Secondary	Organ Dysfunction	Up to 28 days after randomization.	Difference in number of organ dysfunctions.
Secondary	PELOD-2 Score	Up to 28 days after randomization.	Difference in PELOD-2 score. Change from randomization to Worst PELOD-2 score. (Pediatric Logistic Organ Dysfunction) Points are on a range of 0-6 and based on Neurologic, cardiovascular, renal, respiratory, and hematologic function. The higher the score the worse the organ failure is and higher mortality rate.
Secondary	Nosocomial Infection	Up to 28 days after randomization.	Difference in nosocomial infection rate.
Secondary	Sepsis, Severe Sepsis, Septic Shock	Up to 28 days after randomization.	Difference in the rate of sepsis, severe sepsis or septic shock.
Secondary	Acute Respiratory Distress Syndrome	Up to 28 days after randomization.	Difference in the rate of acute respiratory distress syndrome.
Secondary	Mechanical Ventilation	Up to 28 days after randomization.	28 day mechanical ventilation free days
Secondary	ICU Free Days	Up to 28 days after randomization	Difference in ICU free days.
Secondary	Mortality	Up to 90 days after randomization	Difference in 90 day mortality.
Secondary	Delirium	up to 72 hours post last study transfusion	Transfusion Associated Delirium in pediatric critically ill children

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)	28 days after randomization	Development of organ dysfunction in all participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Organ Dysfunction	Up to 28 days after randomization.		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	PELOD-2 Score	Up to 28 days after randomization.		score on a scale	MEAN
SECONDARY	Nosocomial Infection	Up to 28 days after randomization.		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Sepsis, Severe Sepsis, Septic Shock	Up to 28 days after randomization.		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Acute Respiratory Distress Syndrome	Up to 28 days after randomization.		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Mechanical Ventilation	Up to 28 days after randomization.		days	MEAN
SECONDARY	ICU Free Days	Up to 28 days after randomization		days	MEDIAN
SECONDARY	Mortality	Up to 90 days after randomization		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Delirium	up to 72 hours post last study transfusion		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group24

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)	Short Storage		147		Participants
Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)	Standard Issue		133		Participants
Organ Dysfunction	Short Storage		129		Participants
Organ Dysfunction	Standard Issue		133		Participants
PELOD-2 Score	Short Storage		0.5	Standard Error 5.8	score on a scale
PELOD-2 Score	Standard Issue		-0.05	Standard Error 4.7	score on a scale
Nosocomial Infection	Short Storage		24		Participants
Nosocomial Infection	Standard Issue		23		Participants
Sepsis, Severe Sepsis, Septic Shock	Short Storage	Sepsis	160		Participants
Sepsis, Severe Sepsis, Septic Shock	Standard Issue	Sepsis	154		Participants

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Short Storage	768
Overall Study	STARTED	Standard Issue	770
Overall Study	COMPLETED	Short Storage	728
Overall Study	COMPLETED	Standard Issue	733
Overall Study	NOT COMPLETED	Short Storage	40
Overall Study	NOT COMPLETED	Standard Issue	37

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	Deep Vein Thrombosis	Blood and lymphatic system disorders	Short Storage	20	728
serious	Deep Vein Thrombosis	Blood and lymphatic system disorders	Standard Issue	14	733
serious	Hemolytic Transfusion Reaction	Blood and lymphatic system disorders	Short Storage	0	728
serious	Hemolytic Transfusion Reaction	Blood and lymphatic system disorders	Standard Issue	1	733
serious	Hyperkalemia	Blood and lymphatic system disorders	Short Storage	30	728
serious	Hyperkalemia	Blood and lymphatic system disorders	Standard Issue	36	733
serious	Hypocalemia	Blood and lymphatic system disorders	Short Storage	10	728
serious	Hypocalemia	Blood and lymphatic system disorders	Standard Issue	13	733
serious	Major Allergic Reaction	Immune system disorders	Short Storage	2	728
serious	Major Allergic Reaction	Immune system disorders	Standard Issue	2	733

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Short Storage	49	716
Total, all-cause mortality	Standard Issue	45	714
Total, other adverse events	Short Storage	0	728
Total, other adverse events	Standard Issue	0	733
Total, serious adverse events	Short Storage	80	728
Total, serious adverse events	Standard Issue	84	733

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30055634	DERIVED	PubMed
31821429	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01HL116383	Age of Blood in Children in Pediatric Intensive Care Units	SPINELLA, PHILIP C	WASHINGTON UNIVERSITY	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2013 to 2018

Source NIH RePORTER

Trial comparisons8

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Short Storage vs Standard Issue: Acute Respiratory Distress Syndrome	Trial comparisons
Short Storage vs Standard Issue: Nosocomial Infection	Trial comparisons
Short Storage vs Standard Issue: Delirium	Trial comparisons
Short Storage vs Standard Issue: Organ Dysfunction	Trial comparisons
Short Storage vs Standard Issue: Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)	Trial comparisons
Short Storage vs Standard Issue: deaths from any cause	Trial comparisons
Short Storage vs Standard Issue: Mortality	Trial comparisons
Short Storage vs Standard Issue: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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