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โ† Trials
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Feasibility Performance Study of ABL90 FLEX PLUS HEM

Recruitingn/aAges 18 Years - anyAllRadiometer Medical ApS
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In plain words

What the trial is, and whether it could suit you

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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๐Ÿ“‹ Eligibility rules (as published)
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 * Subject with an invalid written informed consent or who has withdrawn consent.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.
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What it tests

  • 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
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Where

1 site
Bispebjerg Hospital
Copenhagen, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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