The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study

Karolinska Institutet76 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Thrombocytopenia

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (2)

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

Outcomes

Primary Outcomes

Neo-BAT score (Neo-BAT: Neonatal Bleeding Assessment Tool)

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.

Time frame: study period: 5 days

Secondary Outcomes

Number of thrombotic events

Time frame: up to post-conceptional age 36 weeks