Critical Care, Intensive CareNCT07491731
Zeus (510K) - 24024 - Stability in Venous and Arterial Blood
An observational study of Critical Care, Intensive Care, run by Radiometer Medical ApS at 3 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Intensive Care
- What is being tested?
- Aspirating syringes PICO A and safePICO A
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 43 participants
- Where
- 3 sitesDenmark
- Study dates
- 7 Oct 2025to 9 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Hvidovre Hospital
Hvidovre
Bispebjerg Hospital, Itensiv afsnit
København NV, 2400
Sjællands Universitetshospital Køge
Køge
About this study
Official title: 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.
Read the 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
- Being tested
- Aspirating syringes PICO A and safePICO A
- Keywords
- PICO A, safePICO A, Stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirating syringes PICO A and safePICO ADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| PICO A and safePICO A | Observational, prospective study Receives: Device: Aspirating syringes PICO A and safePICO A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One subject delivers blood samples to be measured over time (45 min.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start7 Oct 2025
- Primary completion10 Dec 2025
- Study completion9 Jan 2026
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Care, Intensive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiometer Medical ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491731
- Sponsor's protocol ID
- DC-091350
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24024 - Clinical In-use Analyte Stability Study for 17 Parameters in Venous and Arterial Blood for PICO A and safePICO A
- ClinicalTrials.gov ID
- NCT07491731
- Acronym / sponsor ID
- DC-091350
- Conditions
- Critical Care, Intensive Care
- Keywords
- PICO A, safePICO A, Stability
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Radiometer Medical ApSIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PICO A and safePICO A | – | Device: Aspirating syringes PICO A and safePICO AObservational, prospective study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirating syringes PICO A and safePICO APICO 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. | Device | PICO A and safePICO A |
Primary outcome
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).
Time frame: One subject delivers blood samples to be measured over time (45 min.)
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Care, Intensive Care, run by Radiometer Medical ApS at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: One subject delivers blood samples to be measured over time (45 min.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.