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NCT Number: NCT02371330

The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia 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.

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Key information

Conditions

Thrombocytopenia Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Astrid Lindgren Children's Hospital, Karolinska University Hospital, Stockholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 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 outcomes

  1. Number of thrombotic events

    Time frame: up to post-conceptional age 36 weeks

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

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

Acronym: Neo-HAT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2015
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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