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Completed
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.
Conditions: Sepsis, Sepsis Bacterial
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 46
Sponsor: Abionic SA
Location: France
Summary
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.
Eligibility Criteria
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 hospitalNeed for venous and arterial blood samples as part of standard of careCovered 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.
Source: ClinicalTrials.gov (NCT05627076). StuddyBuddy aggregates publicly available trial information.