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

NCT07491731 | Terminated

• 1 other identifier: DC-091350
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Critical Care, Intensive Care

Keywords

PICO A; safePICO A; Stability

Outcome Measures

Primary Outcomes (1)

• In-use analyte stability in adult arterial and venous whole blood in PICO A and safePICO A for each parameter, measuring at five testing timepoints measured in minutes (t=0, t=10, t=20, t=30, t=45).

  One subject delivers blood samples to be measured over time (45 min.)

Study Arms (1)

PICO A and safePICO A

Observational, prospective study

Device: Aspirating syringes PICO A and safePICO A

Interventions

Aspirating syringes PICO A and safePICO A DEVICE

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.

PICO A and safePICO A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients 18 years or older, critically ill, but still able to understand and sign the informed consent form and admitted to the hospital having an arterial catheter line established as part of standard of care to minimize the risk to the patient when having blood samples drawn. To reach reportable concentrations of the 17 parameters covering the reportable range as much as possible the subject will be a patient in the intensive care unit or another unit corresponding to the emergency care.

You may qualify if:

• Subjects must meet all the criteria listed below to be eligible for participation in the study.
• Subject must be 18 years of age or older.
• Subject must have an arterial and/or venous line established as a part of the standard of care.
• Subject evaluated by the principal investigator or designee as suitable for the study according to the protocol.

You may not qualify if:

• Subjects meeting any of the criteria listed below will not be eligible for participation in the study.
• Subjects, who are pregnant or breastfeeding.
• Subjects who have been previously enrolled into this study.
• Subjects exposed to following substances within the last 72 hours:
• Acetylsalicylic Acid Sodium Salt at dose equal or above 1 gram/day
• Acetylcysteine
• Fluorescein dye
• Patent Blue dye

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (3)

Hvidovre Hospital

Hvidovre, Denmark

Location

Bispebjerg Hospital, Itensiv afsnit

København NV, 2400, Denmark

Location

Sjællands Universitetshospital Køge

Køge, Denmark

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: March 24, 2026
• Study Start: October 7, 2025
• Primary Completion: December 10, 2025
• Study Completion: January 9, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-01

Locations

DK (3)