The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study

The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study - Neo-HAT Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02371330

Acronym

Neo-HAT

Enrollment

Registered

2015-02-25

Start date

2015-04-30

Completion date

2017-09-30

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia

Keywords

Thrombocytopenia, Neonate, PFA-100, Neo-BAT, Hemorrhage

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Neo-BAT score (Neo-BAT: Neonatal Bleeding Assessment Tool)	study period: 5 days	The NeoBAT is a simple, reliable and objective tool for the standardized assessment of bleeding in neonates, which was developed by an international team of experts based on the World Health Organization bleeding score for adults.

Secondary

Measure	Time frame
Number of thrombotic events	up to post-conceptional age 36 weeks

Countries

Sweden, United States

Outcome results