Trial Outcomes & Findings for Age of Blood in Children in Pediatric Intensive Care Units (NCT NCT01977547)

NCT ID: NCT01977547

Last Updated: 2021-04-29

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1538 participants
• Primary outcome timeframe: 28 days after randomization
• Results posted on: 2021-04-29

Participant Flow

Participant milestones

Measure	Short Storage Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
Overall Study STARTED	768	770
Overall Study COMPLETED	728	733
Overall Study NOT COMPLETED	40	37

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age of Blood in Children in Pediatric Intensive Care Units

Baseline characteristics by cohort

Measure	Short Storage n=728 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=733 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Total n=1461 Participants Total of all reporting groups
Age, Continuous	1.8 year n=5 Participants	1.9 year n=7 Participants	1.8 year n=5 Participants
Sex: Female, Male Female	352 Participants n=5 Participants	339 Participants n=7 Participants	691 Participants n=5 Participants
Sex: Female, Male Male	376 Participants n=5 Participants	394 Participants n=7 Participants	770 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	68 Participants n=5 Participants	82 Participants n=7 Participants	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	515 Participants n=5 Participants	508 Participants n=7 Participants	1023 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	145 Participants n=5 Participants	143 Participants n=7 Participants	288 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	22 Participants n=5 Participants	11 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) Asian	37 Participants n=5 Participants	29 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Black or African American	86 Participants n=5 Participants	103 Participants n=7 Participants	189 Participants n=5 Participants
Race (NIH/OMB) White	399 Participants n=5 Participants	415 Participants n=7 Participants	814 Participants n=5 Participants
Race (NIH/OMB) More than one race	24 Participants n=5 Participants	13 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	155 Participants n=5 Participants	158 Participants n=7 Participants	313 Participants n=5 Participants
Region of Enrollment Canada	196 participants n=5 Participants	194 participants n=7 Participants	390 participants n=5 Participants
Region of Enrollment United States	415 participants n=5 Participants	423 participants n=7 Participants	838 participants n=5 Participants
Region of Enrollment Italy	19 participants n=5 Participants	18 participants n=7 Participants	37 participants n=5 Participants
Region of Enrollment Israel	6 participants n=5 Participants	9 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment France	92 participants n=5 Participants	89 participants n=7 Participants	181 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days after randomization

Population: Development of organ dysfunction in all participants

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.

Outcome measures

Measure	Short Storage n=728 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=732 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
Number of Participants With New or Progressive Multiple Organ Dysfunction Syndrome (NPMODS)	147 Participants	133 Participants

SECONDARY outcome

Timeframe: Up to 28 days after randomization.

Difference in number of organ dysfunctions.

Outcome measures

Measure	Short Storage n=669 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=732 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
Organ Dysfunction	129 Participants	133 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Short Storage n=728 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=733 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
PELOD-2 Score	0.5 score on a scale Standard Error 5.8	-0.05 score on a scale Standard Error 4.7

SECONDARY outcome

Timeframe: Up to 28 days after randomization.

Difference in nosocomial infection rate.

Outcome measures

Measure	Short Storage n=728 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=732 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
Nosocomial Infection	24 Participants	23 Participants

SECONDARY outcome

Timeframe: Up to 28 days after randomization.

Difference in the rate of sepsis, severe sepsis or septic shock.

Outcome measures

Measure	Short Storage n=619 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=608 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
Sepsis, Severe Sepsis, Septic Shock Sepsis	160 Participants	154 Participants
Sepsis, Severe Sepsis, Septic Shock Severe Sepsis	63 Participants	60 Participants
Sepsis, Severe Sepsis, Septic Shock Septic Shock	59 Participants	57 Participants

SECONDARY outcome

Timeframe: Up to 28 days after randomization.

Difference in the rate of acute respiratory distress syndrome.

Outcome measures

Measure	Short Storage n=619 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=608 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
Acute Respiratory Distress Syndrome	41 Participants	29 Participants

SECONDARY outcome

Timeframe: Up to 28 days after randomization.

28 day mechanical ventilation free days

Outcome measures

Measure	Short Storage n=728 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=733 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
Mechanical Ventilation	25.4 days Interval 19.6 to 27.9	25.8 days Interval 20.2 to 28.0

SECONDARY outcome

Timeframe: Up to 28 days after randomization

Difference in ICU free days.

Outcome measures

Measure	Short Storage n=728 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=733 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
ICU Free Days	21.9 days Interval 14.5 to 25.3	22.0 days Interval 16.1 to 25.6

SECONDARY outcome

Timeframe: Up to 90 days after randomization

Difference in 90 day mortality.

Outcome measures

Measure	Short Storage n=716 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=714 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
Mortality	49 Participants	45 Participants

SECONDARY outcome

Timeframe: up to 72 hours post last study transfusion

Transfusion Associated Delirium in pediatric critically ill children

Outcome measures

Measure	Short Storage n=69 Participants Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=77 Participants Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
Delirium	55 Participants	54 Participants

Adverse Events

Short Storage

Serious events: 80 serious events

Other events: 0 other events

Deaths: 49 deaths

Standard Issue

Serious events: 84 serious events

Other events: 0 other events

Deaths: 45 deaths

Serious adverse events

Measure	Short Storage n=728 participants at risk Red blood cells storage duration of equal to or less than 7 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit	Standard Issue n=733 participants at risk Red blood cells storage duration of 2 to 42 days with an expected average length of storage of about 17-21 days. Short storage RBC age: IND obtained to cover the expiration date on the red blood cell unit
Blood and lymphatic system disorders Deep Vein Thrombosis	2.7% 20/728 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.	1.9% 14/733 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.
Blood and lymphatic system disorders Hemolytic Transfusion Reaction	0.00% 0/728 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.	0.14% 1/733 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.
Blood and lymphatic system disorders Hyperkalemia	4.1% 30/728 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.	4.9% 36/733 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.
Blood and lymphatic system disorders Hypocalemia	1.4% 10/728 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.	1.8% 13/733 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.
Immune system disorders Major Allergic Reaction	0.27% 2/728 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.	0.27% 2/733 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.
Respiratory, thoracic and mediastinal disorders Nosocomial Pneumonia	2.5% 18/728 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.	2.0% 15/733 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.
Blood and lymphatic system disorders Transfusion Associated Cardiac Overload	0.00% 0/728 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.	0.41% 3/733 • 28 days for Adverse Events 90 days for mortality There is a change in the number of patients evaluated due to being lost to follow up in certain events.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Philip C. Spinella

Washington University School of Medicine

Phone: 3142860858

Email: pspinella@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place