The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia (NEOHAT-2)

March 21, 2023 updated by: Emoke Deschmann, Karolinska Institutet

The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study-2

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.

Study Overview

Status

Recruiting

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 Type

Observational

Enrollment (Anticipated)

250

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

      • Amsterdam, Netherlands
        • Not yet recruiting
        • Amsterdam University Medical Centre
      • Leiden, Netherlands
        • Not yet recruiting
        • Leiden University Medical Center
      • Huddinge, Sweden
        • Recruiting
        • Karolinska University Hospital Huddinge campus
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital Solna campus, Astrid Lindgren Children's Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
    • Utah
      • Murray, Utah, United States, 84107
        • Not yet recruiting
        • Intermountain Medical Center
      • Provo, Utah, United States, 84604
        • Not yet recruiting
        • Utah Valley Hospital

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

1 day and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

- Infants will be eligible for study if they have a gestational age <32 weeks and a birth weight ≥500 grams; and have a platelet count <100 x 109/L.

Description

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).

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
NeoBAT score
Time Frame: 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.
24 hours

Collaborators and Investigators

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

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 (Actual)

June 15, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • TRF15483
  • 2P01HL046925-21A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Bleeding

3
Subscribe