Clinical Trial

Zeus (510K) - 24024 - Stability in Venous and Arterial Blood

Terminated
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Why the trial stopped
Change in supply chain challenges and the need to manufacture the PICO A and safePICO A syringes, which the study was designed to validate, is no longer required.
Summary
The purpose is to determine the in-use stability of 17 parameters (pH, pCO2, pO2, cNa+, cCa2+, cCl-, cK+, cGlu, cLac, ctHb, sO2, FMetHb, FCOHb, FO2Hb, FHHb, FHbF \& ctBil) in adult arterial and venous whole blood drawn and stored in aspirating syringes (PICO A and safePICO A) measured on ABL90 FLEX PLUS analyzer. The study aims to determine the in-use sample stability for up to 45 min at room temperature (18-25 °C) for arterial and venous blood sample analysis in the PICO A and safePICO A syringes for all 17 parameters.
Trial Details
NCT Number NCT07491731
Lead Sponsor Radiometer Medical ApS
Conditions Critical Care, Intensive Care
Enrollment 43 participants
Start Date 2025-10-07
Primary Completion 2025-12-10 (estimated)
Study Completion 2026-01-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-24