ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

Congenital Heart Disease Clinical Trial

Official title:

ABL90 Flex Plus Method Comparison Neonatal Arterial, Venous, Capillary Blood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078943
• Other study ID #: DC-083185
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: January 2023
• Source: Radiometer Medical ApS
• Contact: Lone Pedersen, PhD
• Phone: +4528989640
• Email: lone.graasboljuulpedersen[@]radiometer.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal arterial, venous, and capillary whole blood for ctBil and FHbF in a Point of Care (POC) setting.

Description:

The main question it aims to answer is: To quantify the relationship using comparison measurement from the same sample between the test device and the predicate device within the reportable range for ctBil and FHbF in heparinized arterial and venous neonatal whole blood in syringe measuring mode (S65, SP65) and heparinized mixed venous/arterial whole blood samples in capillary measuring mode (C65).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 612
• Est. completion date: January 30, 2024
• Est. primary completion date: January 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

Inclusion Criteria:

• The following are the inclusion criteria for the neonatal subjects:
• The age of the subject must be =28 days.
• Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.
• Subjects having a sample drawn as part of standard of care that meets the requirements for samples in this study. The following are the inclusion criteria for the subjects providing placenta for cord

blood:

• Delivery =38 weeks of gestation.

Exclusion Criteria:

• The following are the exclusion criteria for the neonatal subjects:
• Subject who has already provided successful results from arterial, venous and mixed venous/arterial samples, to cover both syringe modes and the capillary mode and parameters.
• Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.
• Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety). The following are the exclusion criteria for the subjects providing placenta for cord

blood:

• Subjects positive of HIV or Hepatitis C

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Device:
• method comparison
to quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for all ctBil and FHbF in heparinized arterial and venous neonatal whole blood in syringe measuring mode (S65, SP65) and heparinized mixed venous/arterial whole blood samples in capillary measuring mode (C65)

Locations

Country	Name	City	State
United States	St Louis Children's Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Radiometer Medical ApS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Slope, R^2 and bias	Slope, R^2 and bias at medical decision points for each combination of modes and sample type	6-9 months