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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04598750
Other study ID # TRF15483
Secondary ID 2P01HL046925-21A
Status Recruiting
Phase
First received
Last updated
Start date June 15, 2021
Est. completion date December 31, 2024

Study information

Verified date March 2023
Source Karolinska Institutet
Contact Emöke Deschmann, MD, PhD
Phone +46 73 539 5575
Email emoke.deschmann@sll.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Day and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Netherlands Amsterdam University Medical Centre Amsterdam
Netherlands Leiden University Medical Center Leiden
Sweden Karolinska University Hospital Huddinge campus Huddinge
Sweden Karolinska University Hospital Solna campus, Astrid Lindgren Children's Hospital Stockholm
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston Children's Hospital Boston Massachusetts
United States Intermountain Medical Center Murray Utah
United States Utah Valley Hospital Provo Utah

Sponsors (7)

Lead Sponsor Collaborator
Karolinska Institutet Boston Children's Hospital, Harvard Medical School (HMS and HSDM), Karolinska University Hospital, National Heart, Lung, and Blood Institute (NHLBI), Region Stockholm, The Swedish Society of Medicine

Countries where clinical trial is conducted

United States,  Netherlands,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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