The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study

Completed

• Conditions: Thrombocytopenia

• Registration Number: NCT02371330
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-25
• Study Start: 2015-04
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-14
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of thrombotic events	up to post-conceptional age 36 weeks

Trial Locations

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