The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study
Completed
Conditions studied: Thrombocytopenia
In brief
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.
Key facts
- Study ID
- NCT02371330
- Run by
- Karolinska Institutet
- People needed
- 76
- Starts
- 2015-04-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2017-11-17
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- <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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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