Age of Blood in Children in Pediatric Intensive Care Units



Status:Completed
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any - 15
Updated:3/28/2019
Start Date:January 2014
End Date:December 2018

Use our guide to learn which trials are right for you!

ABC PICU is a randomized clinical trial that will compare the clinical consequences of RBC
storage duration in 1538 critically ill children. Laboratory and observational evidence
points to serious concerns about the lack of safety and effectiveness of older RBCs,
especially in more vulnerable populations. Physicians and institutions have been
systematically transfusing fresh RBCs to some pediatric patients primarily because of beliefs
that the use of fresh RBCs improve outcomes. Conversely, the standard practice of blood banks
is to deliver the oldest RBC unit in order to decrease blood wastage. To provide much needed
high quality evidence to answer the question "do RBCs of reduced storage duration improve
outcomes?" The ABC PICU Trial will conduct a RCT comparing development of New or Progressive
Multiple Organ Dysfunction Syndrome (NPMODS) in critically ill children transfused with
either RBCs stored ≤ 7 days or standard issue RBCs (expected mean RBC storage duration of
17-21 days).


Patients are considered eligible to participate in the trial if one of the following occur:

1. First RBC transfusion is requested within the first 7 days (168 hours) of ICU
admission.

OR

2. First RBC transfusion is requested for a patient in the Emergency Room, and the PICU
team is involved with the clinical care of the patient, and the patient will
definitively be transferred to the ICU.

OR

3. Patient assessed pre-operatively and for whom ICU admission is planned
post-operatively, and who is determined to definitively require a first RBC
transfusion during surgery.

Inclusion Criteria:

Eligible critically ill pediatric patients who have an expected length of stay after
transfusion in the ICU > 24 hours based on the best judgment of the attending ICU staff.

Exclusion Criteria:

- Age at time of enrollment < 3 days from birth or has reached their 16th birthday.

- Post-conception age < 36 weeks at time of enrollment

- Documented RBC transfusion within the 28 days prior to fulfilling the eligibility
criteria

- Previously randomized in this study

- Weight < 3.0 kg on ICU admission

- Known Pregnancy

- Conscious objection or unwillingness to receive blood products

- Not expected to survive beyond 24 hours, brain death or suspected brain death

- Limitation or withdrawal of care decisions have been made

- Enrollment in another randomized clinical trial which has not been approved for
co-enrollment

- Patients for whom autologous and/or directed donation RBCs will be provided

- Patients for whom the treating physician routinely and systematically requests RBC ≤
14 days of storage

- Patients for whom there systematically exist RBC aliquoting policies that mandate the
initial use of units stored ≤ 14 days (ex: Pedi-Pack).

- On ECMO or plan to be immediately placed on ECMO at time of enrollment

- Patient predicted or presumed to require a massive transfusion (> 40ml/kg of all blood
components in a 24 hour period) according to treating physician judgment

- Refusal by physician

- Inability to obtain consent

- Blood bank personnel experiences difficulties in securing blood products (difficult
cross matches, rare blood groups and diseases like IgA deficiency)

- Insufficient number of ABO type compatible RBC units available in the blood bank at
randomization with a storage time ≤ 7 days (minimum 1 unit regardless of patient age)

- All RBC units available for the patient are not leukocyte-reduced prior to storage
We found this trial at
21
sites
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
702 Barnhill Drive
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Edmonton, Alberta
?
mi
from
Edmonton,
Click here to add this to my saved trials
1600 Southwest Archer Road
Gainesville, Florida 32608
Phone: 352-219-1374
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
?
mi
from
Houston, TX
Click here to add this to my saved trials
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
Park Ridge, Illinois 60540
Phone: 847-723-7157
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
Rochester, New York 14642
?
mi
from
Rochester, NY
Click here to add this to my saved trials
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Tucson, Arizona 85721
?
mi
from
Tucson, AZ
Click here to add this to my saved trials