Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
2008-10-31
2011-03-31
Brief Summary
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This study is investigating using platelet size rather than platelet number as a guideline for transfusing platelets in infants who are hospitalized in a NICU (neonatal intensive care unit). After obtaining parental informed consent, thrombocytopenic infants will be randomized to one of two groups. 1: Transfusion based on platelet number; 2: transfusion based on a combination of platelet number and platelet mass. In each group the decision to transfuse platelets will be made using a slightly different, yet strict set of transfusion rules.
The objective is to determine the feasibility, rate of bleeding complications and compliance of transfusing neonates based on platelet mass rather than platelet number.
The investigators hypothesize that transfusing platelets based on platelet mass will not increase bleeding complications and will reduce the number of transfusions in thrombocytopenic neonates.
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Platelet Number
Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to the total number of platelets
No interventions assigned to this group
Platelet Mass
Infants randomized to this group will be transfused based on a specific set of transfusion guidelines pertaining to a combination of platelet number and platelet size (mass)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
12 Months
ALL
No
Sponsors
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Alfred I. duPont Hospital for Children
OTHER
Thomas Jefferson University
OTHER
Abington Memorial Hospital
OTHER
Christiana Care Health Services
OTHER
Responsible Party
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Christiana Care Health Systems
Principal Investigators
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Jody L Zisk, DO
Role: PRINCIPAL_INVESTIGATOR
Christiana Care Health Services
David A Paul, MD
Role: PRINCIPAL_INVESTIGATOR
Christiana Care Health Systems
Locations
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Christiana Care Health System
Newark, Delaware, United States
A.I. duPont Hospital for Children
Wilmington, Delaware, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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28156
Identifier Type: -
Identifier Source: org_study_id
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