Expired Study
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Charlotte, North Carolina 28203


Purpose:

This is a prospective longitudinal study that evaluates Platelet Function Analyzer-100 (PFA-100) CT-ADPs (closure time-ADP) and incidence of bleeding using the Neonatal Bleeding Assessment Tool - Neo-BAT in preterm neonates <32 weeks gestational age or with a birth weight <1500 grams and with different degrees of thrombocytopenia. 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.


Criteria:

Inclusion Criteria: - <32 weeks gestation or with a birth weight <1500 grams; - 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 not expected to survive by the Attending Neonatologist; - 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.


NCT ID:

NCT02371330


Primary Contact:

Principal Investigator
Emoke Deschmann, M.D., M.M.Sc.
Department of Women's and Children's Health, Karolinska Institutet


Backup Contact:

N/A


Location Contact:

Charlotte, North Carolina 28203
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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