Atellica VTLi Sample matrix study for Plasma Separation Membrane Comparison

Atellica VTLi Sample matrix study for Plasma Separation Membrane Comparison - Atellica VTLi Plasma separation Membrane Comparison

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51710

Enrollment

100

Registered

2022-09-28

Start date

2022-06-01

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart attack Myocardial Infarction

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • >=22 years old • Patients presenting at the coronary care unit with suspected/diagnosed ACS and thus having suspected elevated cTnI values • Patients willing and able to sign informed consent form

Exclusion criteria

Exclusion criteria: • Patients younger than 22 years • Patients requiring emergency treatment • Patients with cognitive impairment or inability to understand study information • Patients previously enrolled in this study • Pregnant or breastfeeding women

Design outcomes

Primary

Measure	Time frame
The differences between the filters will be analysed using Passing-Bablok regression, according to CLSI EP09c from the Clinical and Laboratory Standards Institute. The parameter to be assessed is the significance of the Passing-Bablok regression, which is performed for each different sample type. Additionally, for each sample type, the measurement results of the filters should demonstrate a correlation coefficient (R) of at least 0.95 Furthermore, the venous whole blood and plasma results as a function of hematocrit for the alternative filter(s) will be analyzed.	—

Measure

Time frame

The differences between the filters will be analysed using Passing-Bablok regression, according to CLSI EP09c from the Clinical and Laboratory Standards Institute. The parameter to be assessed is the significance of the Passing-Bablok regression, which is performed for each different sample type. Additionally, for each sample type, the measurement results of the filters should demonstrate a correlation coefficient (R) of at least 0.95 Furthermore, the venous whole blood and plasma results as a function of hematocrit for the alternative filter(s) will be analyzed.

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Countries

Netherlands

Outcome results