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NEOHAT-2: The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia

Sponsor
Karolinska Institutet (Other)
Overall Status
Recruiting
CT.gov ID
NCT04598750
Collaborator
Karolinska University Hospital (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH), Boston Children's Hospital (Other), Harvard Medical School (HMS and HSDM) (Other), Region Stockholm (Other), The Swedish Society of Medicine (Other)
250
Enrollment
8
Locations
20.5
Anticipated Duration (Months)
31.3
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective observational study designed to evaluate Immature Platelet Fraction or Immature Platelet Count and Platelet Function Analyzer-100/200 Closure Time-ADP (in vitro bleeding time) as markers of bleeding risk in thrombocytopenic preterm neonates admitted to the Neonatal Intensive Care Unit.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Thrombocytopenia is a known risk factor for clinically significant bleeding in neonates. However, there is a poor correlation between degree of thrombocytopenia and bleeding risk. A better marker of bleeding risk suitable for use in neonates could help physicians more accurately determine the risk/benefit ratio of platelet transfusions, guiding platelet transfusion decisions, and potentially protecting vulnerable infants from exposure to unnecessary transfusion-related risks. The investigators recently found that the Platelet Function Analyzer (PFA) Closure Time-Collagen/ADP (CT-ADP) was a better marker of bleeding than the platelet count in preterm neonates. However, the CT-ADP requires 0.8 mL blood limiting its potential widespread use. The Immature Platelet Fraction (IPF) is a new laboratory marker measuring the % newly released and more active platelets, measured from the same sample as the platelet count. This is a prospective observational study designed to evaluate IPF as marker of bleeding risk in thrombocytopenic neonates admitted to the Neonatal Intensive Care Unit, compared to platelet counts alone. And also, to validate the previously found association between PFA-100/200 CT-ADP and bleeding in a bigger cohort, to compare the IPF with the PFA-100/200 CT-ADP as bleeding predictors and to assess whether the PFA-100/200 CT-ADP combined with the IPF is able to predict bleeding in thrombocytopenic preterm neonates.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study-2
    Actual Study Start Date :
    Jun 15, 2021
    Anticipated Primary Completion Date :
    Feb 28, 2023
    Anticipated Study Completion Date :
    Feb 28, 2023

    Outcome Measures

    Primary Outcome Measures

    1. NeoBAT score [24 hours]

      NeoBAT scores will include any bleeding since the last platelet count or over the prior 24 hours, whichever is shortest. This will serve to correlate bleeding scores (NeoBAT) with platelet counts, IPF% and IPC, PFA-100/200 CT-ADP, and to quantify changes in response to platelet transfusions. The scale is 1 to 4 with 1 being Minor Hemorrhage and 4 being Severe Hemorrhage.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have a gestational age <32 weeks and a birth weight ≥500 grams;

    • Have a platelet count <100 x 109/L; and

    • Have a parent/guardian willing to provide written informed consent.

    Exclusion Criteria:

    • Are not expected to survive for >24 hours by the Attending Neonatologist;

    • Are thought to have a familial thrombocytopenia or platelet dysfunction, based on family history or clinical presentation (associated congenital malformations, platelet morphology).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Children's Hospital Boston Massachusetts United States 02115
    2 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    3 Intermountain Medical Center Murray Utah United States 84107
    4 Utah Valley Hospital Provo Utah United States 84604
    5 Amsterdam University Medical Centre Amsterdam Netherlands
    6 Leiden University Medical Center Leiden Netherlands
    7 Karolinska University Hospital Huddinge campus Huddinge Sweden
    8 Karolinska University Hospital Solna campus, Astrid Lindgren Children's Hospital Stockholm Sweden

    Sponsors and Collaborators

    • Karolinska Institutet
    • Karolinska University Hospital
    • National Heart, Lung, and Blood Institute (NHLBI)
    • Boston Children's Hospital
    • Harvard Medical School (HMS and HSDM)
    • Region Stockholm
    • The Swedish Society of Medicine

    Investigators

    • Principal Investigator: Emöke Deschmann, MD, PhD, Karolinska Institutet
    • Study Chair: Robert Christensen, MD, University of Utah Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Emoke Deschmann, Principal Investigator, Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT04598750
    Other Study ID Numbers:
    • TRF15483
    • 2P01HL046925-21A1
    First Posted:
    Oct 22, 2020
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thrombocytopenia
    Thrombocytopenia, Neonatal Alloimmune

    Study Results

    No Results Posted as of Sep 16, 2021