The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia

Bleeding Clinical Trial

— NEOHAT-2  

Official title:

The Neonatal Hemorrhagic Risk Assessment in Thrombocytopenia Study-2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04598750
• Other study ID #: TRF15483
• Secondary ID: 2P01HL046925-21A
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Bleeding
• Neonatal Thrombocytopenia
• Thrombocytopenia

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