NCT07491731

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

24024 - Clinical In-use Analyte Stability Study for 17 Parameters in Venous and Arterial Blood for PICO A and safePICO A

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Radiometer Medical ApS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In-use analyte stability study for 17 parameters. The stability study is a 5 time-point study analyzing five (5) syringes at T = 0 min, 10 min, 20 min, 30 min and 45 min. after sample collection. Series of five (5) syringes are collected from each investigational device safePICO A and PICO A. Each type of syringe will be analyzed on one ABL90 Flex Plus analyzer and for both types of blood (Arterial or Venous). For each syringe type a minimum of 50 + 7 series (7 contrived series) with samples within the reportable ranges will need to be tested for each blood type.

Conditions

• Critical Care, Intensive Care

Interventions

Type	Name	Description
DEVICE	Aspirating syringes PICO A and safePICO A	PICO A: The PICO A is a pre-heparinized, aspirating blood syringe. The PICO A covers a volume range of 0.5-1.0 mL. The PICO A consists of a barrel, plunger, and a piston. PICO A is supplied with a heparinized paper brick within the barrel. The function of the heparin brick is to minimize coagulation of blood within the blood gas syringe. In addition, the syringe is delivered with a tip cap to reduce the risk of blood contact during blood mixing and sample transportation. safePICO A: The safePICO A is a pre-heparinized, aspirating blood syringe. The syringe consists of a barrel, plunger, and piston. It contains a mixing ball that supports automatic blood mixing when inserted in the sample mixing inlet integrated in the ABL90 FLEX PLUS analyzer. The safePICO A covers a volume range of 0.7-1.0 mL. The syringe includes a vented tip cap (VTC), which simplifies removal of air bubbles and minimize the risk of contact with patient blood by sealing the sample.

Timeline

• Start date: 2025-10-07
• Primary completion: 2025-12-10
• Completion: 2026-01-09
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

3 sites across 1 country: Denmark