The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia
NEOHAT-2
2 other identifiers
observational
250
3 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedOctober 9, 2024
October 1, 2024
4.5 years
October 16, 2020
October 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
NeoBAT score
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
Eligibility Criteria
\- 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.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Karolinska University Hospitalcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- Boston Children's Hospitalcollaborator
- Harvard Medical School (HMS and HSDM)collaborator
- Region Stockholmcollaborator
- The Swedish Society of Medicinecollaborator
Study Sites (8)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
Utah Valley Hospital
Provo, Utah, 84604, United States
Amsterdam University Medical Centre
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Karolinska University Hospital Huddinge campus
Huddinge, Sweden
Karolinska University Hospital Solna campus, Astrid Lindgren Children's Hospital
Stockholm, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emöke Deschmann, MD, PhD
Karolinska Institutet
- STUDY CHAIR
Robert Christensen, MD
University of Utah Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 16, 2020
First Posted
October 22, 2020
Study Start
June 15, 2021
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
October 9, 2024
Record last verified: 2024-10