The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia

Recruiting

• Conditions: Bleeding; Neonatal Thrombocytopenia

• Registration Number: NCT04598750
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-22
• Study Start: 2021-06-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (8)

Karolinska University Hospital Huddinge campus; 🇸🇪 Huddinge, Sweden

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Karolinska University Hospital Solna campus, Astrid Lindgren Children's Hospital; 🇸🇪 Stockholm, Sweden

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Utah Valley Hospital; 🇺🇸 Provo, Utah, United States

Amsterdam University Medical Centre; 🇳🇱 Amsterdam, Netherlands

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States