Status:
COMPLETED
A Study to Observe the Causes and Treatment of Anemia in Critically Ill Children
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Anemia
Eligibility:
All Genders
Up to 17 years
Brief Summary
The purpose of this study is to determine the incidence of anemia and blood transfusions and management of these in critically ill children
Detailed Description
Critically ill patients admitted to the intensive care unit often have anemia from one or more of a number of possible causes including blood loss due to surgery or injury, frequent blood sampling, ch...
Eligibility Criteria
Inclusion
- Male or female patients aged 0 to 17 years
- During part 1 of this study, patients must be newly admitted to the Pediatric Intensive Care Unit (PICU) (regardless of stay)
- During part 2 of the study, patients must be newly admitted to the PICU and have stayed there for \> = 48 hours
- Patients' legally acceptable representatives must have signed an informed consent
- Patients aged 7 years and above must give assent if or when they are physically capable
Exclusion
- Premature infants (patients who were born at \< = 37 weeks who are \< 28 days old)
- Patients who have previously participated in this study
- Patients from a family unwilling to receive blood transfusions (for example for religious reasons)
- Patients who are participating in any other transfusion or blood-related research at the time of entry into the study or any time during the study
- Patients who are known to be pregnant (no pregnancy test will be performed in this study)
- Patients with known or suspected brain death
- Patients who have had a Pediatric Intensive Care Unit (PICU) stay of longer than 72 hours within the 7 days prior to entering the study
Key Trial Info
Start Date :
September 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
1201 Patients enrolled
Trial Details
Trial ID
NCT00211055
Start Date
September 1 2004
End Date
March 1 2005
Last Update
April 16 2013
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