HemolysisABL90FLEXHEMNCT07345091
Feasibility Performance Study of ABL90 FLEX PLUS HEM
An observational study of Hemolysis, run by Radiometer Medical ApS at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemolysis
- What is being tested?
- 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
- How many people
- 95 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Aug 2025to 10 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults, 18 years of age or older, that have been admitted to the hospital and undergo blood collection as part of their standard care.
Who may be able to join
- 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.
Who cannot join
- 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- Subject with an invalid written informed consent or who has withdrawn consent.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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Bispebjerg Hospital
Copenhagen, NV, 2400
Theis Itenov, MD, PhD, +45 51 34 19 45, theis.skovsgaard.itenov@regionh.dk
About this study
Official title: Feasibility Performance Study Protocol for 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.
Read the detailed description
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.
- Conditions
- Hemolysis
- Being tested
- 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
- Keywords
- IVDR, Blood Gas Analyser, In vitro diagnostic, hemolysis detection
- Medical subject headings
- Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 bloodDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Adults, 18 years of age or older, that have been admitted to hospital and undergo blood collection | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of sample analysis (single session per sample; Day 1)
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: At time of native sample analysis (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start4 Aug 2025
- Primary completion10 May 2026 (estimated)
- Study completion10 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemolysisStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiometer Medical ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345091
- Sponsor's protocol ID
- DC-089793-ABL90FLEX-HEM-Rev3
- Acronym
- ABL90FLEXHEM
- Status last verified
- Jan 2026
- First submitted
- 11 Sep 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM
- ClinicalTrials.gov ID
- NCT07345091
- Acronym / sponsor ID
- ABL90FLEXHEM / DC-089793-ABL90FLEX-HEM-Rev3
- Conditions
- Hemolysis
- Keywords
- IVDR, Blood Gas Analyser, In vitro diagnostic, hemolysis detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Radiometer Medical ApSIndustry (pharma, biotech, devices)
- Collaborators
- Bispebjerg Hospital
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 10 May 2026 (estimated)
- Study completion
- 10 Jun 2026 (estimated)
- First posted
- 15 Jan 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.
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.
Detailed description
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults, 18 years of age or older, that have been admitted to hospital and undergo blood collection | – | 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 bloodAdults, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults, 18 years of age or older, that have been admitted to the hospital and undergo blood collection as part of their standard care.
Key inclusion criteria (5 listed)
- Subject must be 18 years of age or older
- Informed consent is obtained:
- Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| 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 bloodThe 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. | Diagnostic test | Adults, 18 years of age or older, that have been admitted to hospital and undergo blood collection |
Primary outcome
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.
4 secondary outcomes
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)
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)
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)
Percentage of native whole blood samples with hemolysis (ccfHb > 20 mg/dL)
Time frame: At time of native sample analysis (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemolysis, run by Radiometer Medical ApS at 1 site 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vadim Fedulov (+4526311594, vadim.fedulov@radiometer.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 15 Jan 2026.