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

November 14, 2017 updated by: Emoke Deschmann, Karolinska Institutet

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 171 76
        • Astrid Lindgren Children's Hospital, Karolinska University Hospital
  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Department of Pediatrics, Levine Children's Hospital, Carolinas Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to the Neonatal Intensive Care Unit who are <32 weeks gestation or with a birth weight <1500 grams.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
study period: 5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of thrombotic events
Time Frame: up to post-conceptional age 36 weeks
up to post-conceptional age 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Thrasher Research Fund

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

February 13, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRF-1516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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