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

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT02371330

Collaborator

Thrasher Research Fund (Other)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopenia

Study Design

Study Type:

Observational

Actual Enrollment :

76 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2015

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Number of thrombotic events [up to post-conceptional age 36 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System	Charlotte	North Carolina	United States	28203
2	Astrid Lindgren Children's Hospital, Karolinska University Hospital	Stockholm		Sweden	171 76