ABL90 FLEX PLUS HEM device performance for hemolysis detection
Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM
This will test whether the ABL90 FLEX PLUS HEM device can accurately detect hemolysis in arterial or venous whole blood samples from adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 95 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radiometer Medical ApS Industry-sponsored |
| Locations | 1 site (Copenhagen, NV) |
| Trial ID | NCT07345091 on ClinicalTrials.gov |
What this trial studies
The study will test whole blood samples on the ABL90 FLEX PLUS HEM device and compare its hemolysis-detection results to an established reference method. Testing will be done at a single clinical site by trained personnel following a predefined protocol to ensure consistency. The primary focus is the analytical performance and feasibility of the hemolysis detection function in a real clinical environment. Results will be used to inform future clinical work and potential regulatory submissions.
Who should consider this trial
Good fit: Adults aged 18 or older who can give informed consent (or have a legally designated representative if temporarily incapacitated) and who provide arterial or venous whole blood samples at the participating site.
Not a fit: Pregnant or breastfeeding individuals, those who cannot provide valid consent, or patients for whom sample collection would pose unnecessary risk are excluded and will not receive potential benefit from participation.
Why it matters
Potential benefit: If successful, the device could provide faster, reliable point-of-care detection of hemolysis and help reduce repeat blood draws and result delays.
How similar studies have performed: Related hemolysis-detection features on blood gas analyzers have shown promising laboratory validation, but published clinical feasibility data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Copenhagen, NV
- Bispebjerg Hospital — Copenhagen, Nv, Denmark (Recruiting)
Study contacts
- Study coordinator: Vadim Fedulov
- Email: vadim.fedulov@radiometer.dk
- Phone: +4526311594
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.