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 |
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).
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
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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1600 Southwest Archer Road
Gainesville, Florida 32608
Gainesville, Florida 32608
Phone: 352-219-1374
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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