The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study
NCT ID: NCT02371330
Last Updated: 2017-11-17
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
76 participants
OBSERVATIONAL
2015-04-30
2017-09-30
Brief Summary
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The investigators hypothesized that PFA-100 CT-ADP, a global in vitro test of primary hemostasis, will be a better predictor of clinical bleeding in neonates than platelet count alone. A bleeding risk assessment marker could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions in neonates with thrombocytopenia.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Have confirmed moderate-to-severe thrombocytopenia, defined as a platelet count \<100x109/L;
* Have a parent/guardian willing to comply with the protocol and provide written informed consent.
Exclusion Criteria
* Are thought to have a congenital thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (e.g. associated congenital malformations, platelet morphology);
* Have a major chromosomal anomaly such as Trisomy 13, 18, or 21.
ALL
No
Sponsors
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Thrasher Research Fund
OTHER
Karolinska Institutet
OTHER
Responsible Party
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Emoke Deschmann
M.D., M.M.Sc., Attending Neonatologist
Principal Investigators
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Emoke Deschmann, M.D., M.M.Sc.
Role: PRINCIPAL_INVESTIGATOR
Department of Women's and Children's Health, Karolinska Institutet
Locations
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Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System
Charlotte, North Carolina, United States
Astrid Lindgren Children's Hospital, Karolinska University Hospital
Stockholm, , Sweden
Countries
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References
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Deschmann E, Sola-Visner M, Saxonhouse MA. Primary hemostasis in neonates with thrombocytopenia. J Pediatr. 2014 Jan;164(1):167-72. doi: 10.1016/j.jpeds.2013.08.037. Epub 2013 Oct 3.
Other Identifiers
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TRF-1516
Identifier Type: -
Identifier Source: org_study_id