- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04598750
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
Conditions
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
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Amsterdam, Netherlands
- Not yet recruiting
- Amsterdam University Medical Centre
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Leiden, Netherlands
- Not yet recruiting
- Leiden University Medical Center
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Huddinge, Sweden
- Recruiting
- Karolinska University Hospital Huddinge campus
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Stockholm, Sweden
- Recruiting
- Karolinska University Hospital Solna campus, Astrid Lindgren Children's Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
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Boston, Massachusetts, United States, 02215
- Not yet recruiting
- Beth Israel Deaconess Medical Center
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Utah
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Murray, Utah, United States, 84107
- Not yet recruiting
- Intermountain Medical Center
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Provo, Utah, United States, 84604
- Not yet recruiting
- Utah Valley Hospital
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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
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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.
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24 hours
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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
Additional Relevant MeSH Terms
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.
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