ABL90 FLEX PLUS HEM device performance for hemolysis detection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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* Subject with an invalid written informed consent or who has withdrawn consent.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 it's running

• Bispebjerg Hospital
  Copenhagen, Nv, Denmark Recruiting

Study contacts

• Study coordinator: Vadim Fedulov
• Email: vadim.fedulov@radiometer.dk
• Phone: +4526311594

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.