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

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.

Study Overview

• Status: Terminated
• Conditions: Critical Care, Intensive Care
• Intervention / Treatment: Device: Aspirating syringes PICO A and safePICO A

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.

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark
    • Hvidovre Hospital
  • København NV, Denmark, 2400
    • Bispebjerg Hospital, Itensiv afsnit
  • Køge, Denmark
    • Sjællands Universitetshospital Køge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

Subjects must meet all the criteria listed below to be eligible for participation in the study.

1. Subject must be 18 years of age or older.
2. Subject must have an arterial and/or venous line established as a part of the standard of care.
3. Subject evaluated by the principal investigator or designee as suitable for the study according to the protocol.

Exclusion Criteria:

Subjects meeting any of the criteria listed below will not be eligible for participation in the study.

1. Subjects, who are pregnant or breastfeeding.
2. Subjects who have been previously enrolled into this study.

3. 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

PICO A and safePICO A; Observational, prospective study

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.)

Collaborators and Investigators

• Sponsor: Radiometer Medical ApS

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2025
• Primary Completion (Actual): December 10, 2025
• Study Completion (Actual): January 9, 2026

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Stability; PICO A; safePICO A
• Other Study ID Numbers: DC-091350

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No