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OpenTrials
Completed

NCT Number: NCT05627076

Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument.

Currently no PSP study comparaison has been done between venous and arterial whole blood. Abionic would like to confirm the equivalence of the PSP between venous whole blood and arterial whole blood.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Bacterial Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Limoges, Réanimation Polyvalente

Limoges, 87042, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis;
  • Male or female, 18 years of age or older;
  • Patient admitted to hospital
  • Need for venous and arterial blood samples as part of standard of care
  • Covered by a social security scheme.

Exclusion criteria

  • Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;
  • Subject under juridical protection.

Treatment and study plan

Blood sampling

Device

Blood samples will be collected for the PSP measurement using the abioSCOPE.

Primary outcomes

  1. Primary assessment

    Time frame: through study completion, an average of 1.5 months

    Pairwise comparability of test results when performed with K2-EDTA anticoagulated venous whole blood or K2-EDTA anticoagulated arterial whole blood, represented as percent recovery of arterial whole blood compared to venous whole blood, as well as scatter plots with Weighted Deming and Passing Bablok Regression, and bias plots.

Sponsors and collaborators

Lead sponsor

Abionic SA

Industry

Registry information

Official study title

Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 25, 2022
Registry last updated
Nov 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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