The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2015 |
| Contact: | Emoke Deschmann, M.D.,M.M.Sc. |
| Email: | emoke.deschmann@karolinska.se |
| Phone: | +46-70-001-7401 |
The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study - Neo-HAT Study
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.
(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.
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.
We found this trial at
2
sites
Charlotte, North Carolina 28203
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Stockholm, 17176
Phone: +46 70 001 7401
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