The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia

Brief Title

The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia

Official Title

The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study-2

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.
    

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


Primary Outcome

NeoBAT score


Condition

Neonatal Thrombocytopenia



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

250

Start Date

December 1, 2020

Completion Date

December 31, 2022

Primary Completion Date

December 31, 2022

Eligibility Criteria

        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).
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Emöke Deschmann, MD, PhD, +46 73 539 5575, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations


NCT ID

NCT04598750

Organization ID

TRF15483

Secondary IDs

2P01HL046925-21A1

Responsible Party

Principal Investigator

Study Sponsor

Karolinska Institutet

Collaborators

 Karolinska University Hospital

Study Sponsor

Emöke Deschmann, MD, PhD, Principal Investigator, Karolinska Institutet


Verification Date

October 2020