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NCT Number: NCT07345091

Feasibility Performance Study of ABL90 FLEX PLUS HEM

This feasibility performance study evaluates the ABL90 FLEX PLUS HEM device for its analytical performance in a clinical setting. The study aims to evaluate the performance of the hemolysis detection feature.

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Key information

Conditions

Hemolysis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The study is designed to assess the feasibility and performance of the ABL90 FLEX PLUS HEM device in a clinical environment. It will involve testing whole blood samples using the device and comparing results against established reference method. The primary focus is on validating the device's performance of the hemolysis detection function. The study will be conducted at one selected clinical site with trained personnel and will follow a predefined protocol to ensure consistency and reliability of data collection. The outcomes will inform future clinical studies aimed at supporting regulatory submissions and clinical adoption.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be 18 years of age or older
  • Informed consent is obtained:
  • Directly from the subject, if they are competent and able to understand the provided information and voluntarily agree to participate, or
  • If the subject is temporarily incapacitated and unable to provide informed consent at the time of sample collection, written informed consent will be obtained from the subject's legally designated representative (LDR). when the subject regains capacity after enrollment, they will be informed of study inclusion and given the opportunity to withdraw consent.
  • Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.

Exclusion criteria

  • Subject where sample collection is evaluated by PI or designee to impose unnecessary risk.
  • Subject with an invalid written informed consent or who has withdrawn consent.
  • Subject with known pregnancy or who is breastfeeding.

Treatment and study plan

The purpose of this study is to investigate the performance of the hemolysis detection function on the ABL90 FLEX PLUS HEM using arterial or venous whole blood

Diagnostic Test

The hemolysis detection function is a newly developed sample quality feature on the ABL90 FLEX PLUS HEM intended to detect hemolyzed samples and to improve the reliability of the results provided by blood gas analyzer.

Primary outcomes

  1. Percent of samples correctly classified into hemolysis bins (0-4) using ABL90 FLEX PLUS HEM hemolysis flag

    Time frame: At time of sample analysis (single session per sample; Day 1)

    Whole blood samples (native and contrived) are classified into five hemolysis bins based on reference ccfHb (mg/dL): bin 0 (0-100), bin 1 (101-200), bin 2 (201-400), bin 3 (401-1000), bin 4 (>1000). "Correct classification" is the proportion of samples where the ABL90 FLEX PLUS HEM hemolysis flag matches the reference bin assignment.

Secondary outcomes

  1. Slope of change in ccfHb concentration over 0-45 minutes (mg/dL per minute)

    Time frame: 0-45 minutes after t=0 measurement (within one sample session; Day 1)

    For each sample, ccfHb is measured on ABL90 FLEX PLUS HEM at t=0, 15, 30, and 45 minutes (±5 minutes). The outcome is the slope (mg/dL/min) from linear regression of ccfHb versus time over 0-45 minutes.

  2. Pearson correlation coefficient (r) between ABL90 ccfHb (mg/dL) and Cobas 8000 Hemolysis Index (HI)

    Time frame: At time of paired analysis per sample (Day 1)

    Paired measurements are obtained from the same sample: ABL90 FLEX PLUS HEM measures ccfHb (mg/dL) in S65 mode, and Roche cobas 8000 reports Hemolysis Index (HI) using the hemolysis index assay. The outcome is the Pearson correlation coefficient (r) across paired ABL90 ccfHb and Cobas HI values (unitless r).

  3. Pearson correlation coefficient (r) between ccfHb and potassium concentration (cK+, mmol/L) after RMED aspiration manipulation

    Time frame: During RMED manipulation session (baseline to after 2 aspiration rounds; Day 1)

    For each sample, ABL90 FLEX PLUS HEM measures ccfHb and potassium (cK+) at baseline (no manipulation), after 1 round of RMED aspiration manipulation, and after 2 rounds. The outcome is Pearson correlation coefficient (r) between ccfHb and potassium values pooled across the three measurements (unitless r).

  4. Percentage of native whole blood samples with hemolysis (ccfHb > 20 mg/dL)

    Time frame: At time of native sample analysis (Day 1)

    Among native (non-contrived) leftover arterial and venous whole blood samples, the outcome is the percentage of samples with ccfHb > 20 mg/dL as measured on ABL90 FLEX PLUS HEM.

Study contacts

Contact information is provided by the study sponsor or research team.

Vadim Fedulov

CONTACT

[email protected]

+4526311594

Sponsors and collaborators

Lead sponsor

Radiometer Medical ApS

Industry

Collaborators

  • Bispebjerg Hospital

Registry information

Official study title

Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM

Acronym: ABL90FLEXHEM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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