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NCT01977547 · ClinicalTrials.gov registry record · Phase 3
Age of Blood in Children in Pediatric Intensive Care Units
A Phase 3 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,538
- Enrollment target
NCT01977547 is a Phase 3 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 1,538 participants.
The verdict
NCT01977547, a Phase 3 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,538 participants
- Enrollment target
Study Summary
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).
Interventions
- BIOLOGICAL Short storage RBC age
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,538 participants |
| Start Date | 2014-01 |
| Est. Completion | 2018-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01977547
The ClinicalTrials.gov registry entry for NCT01977547 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,538 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Short storage RBC age is the first listed.
NCT01977547 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01977547 about?
NCT01977547 is a clinical study titled "Age of Blood in Children in Pediatric Intensive Care Units". 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 popula...
What is the current status of trial NCT01977547?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,538 participants. The study started on 2014-01. Estimated completion is 2018-12.
What interventions are being tested in trial NCT01977547?
The interventions under investigation include: Short storage RBC age (BIOLOGICAL).
Who is sponsoring clinical trial NCT01977547?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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