An observational study in Hemolysis, sponsored by Radiometer Medical ApS. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Radiometer Medical ApS (part of Danaher Corporation) · Observational
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.
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.
120 studies on the registry are indexed under Hemolysis; 22 are open to participants now.
This study's planned enrollment of 95 is above the median of 80 across 33 observational studies indexed under Hemolysis.
Browse Hemolysis studies →Radiometer Medical ApS is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
First submitted after Radiometer Medical ApS became part of Danaher Corporation.
Counted across the registry records on this site, refreshed daily.
Adults, 18 years of age or older, that have been admitted to the hospital and undergo blood collection as part of their standard care.
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is obtained:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults, 18 years of age or older, that have been admitted to the hospital and undergo blood collection as part of their standard care will be eligible for participation. Many of these patients are admitted to the Intensive Care Unit (ICU) with acute injury or critical illness and are temporarily unconscious or sedated at the time of admission or during recovery in the intermediate care unit and post-anesthesia care unit due to their medical condition and required treatment (e.g., mechanical ventilation or sedation) and have an A- and or a V-line established for routine sample collection without additional burden as part of their standard care.
Diagnostic Test: 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
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.
Percent of samples correctly classified into hemolysis bins (0-4) using ABL90 FLEX PLUS HEM hemolysis flag
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.
Time frame: At time of sample analysis (single session per sample; Day 1)
Slope of change in ccfHb concentration over 0-45 minutes (mg/dL per minute)
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.
Time frame: 0-45 minutes after t=0 measurement (within one sample session; Day 1)
Pearson correlation coefficient (r) between ABL90 ccfHb (mg/dL) and Cobas 8000 Hemolysis Index (HI)
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).
Time frame: At time of paired analysis per sample (Day 1)
Pearson correlation coefficient (r) between ccfHb and potassium concentration (cK+, mmol/L) after RMED aspiration manipulation
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).
Time frame: During RMED manipulation session (baseline to after 2 aspiration rounds; Day 1)
Percentage of native whole blood samples with hemolysis (ccfHb > 20 mg/dL)
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.
Time frame: At time of native sample analysis (Day 1)
Plan to share: No
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