The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study

NCT02371330 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2017-11-17

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Emoke Deschmann, M.D., M.M.Sc. · Department of Women's and Children's Health, Karolinska Institutet

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States
  • Sweden

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371330 on ClinicalTrials.gov