The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study

Thrombocytopenia Clinical Trial

— Neo-HAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371330
• Other study ID #: TRF-1516
• Status: Completed
• Phase: N/A
• First received: February 13, 2015
• Last updated: November 14, 2017
• Start date: April 2015
• Est. completion date: September 2017

Study information

• Verified date: November 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Thrombocytopenia

Locations

Country	Name	City	State
Sweden	Astrid Lindgren Children's Hospital, Karolinska University Hospital	Stockholm
United States	Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Thrasher Research Fund

Countries where clinical trial is conducted

United States,  Sweden, 

References & Publications (1)

Deschmann E, Sola-Visner M, Saxonhouse MA. Primary hemostasis in neonates with thrombocytopenia. J Pediatr. 2014 Jan;164(1):167-72. doi: 10.1016/j.jpeds.2013.08.037. Epub 2013 Oct 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	study period: 5 days
Secondary	Number of thrombotic events		up to post-conceptional age 36 weeks