Feasibility Performance Study of ABL90 FLEX PLUS HEM
ConditionHemolysis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRadiometer Medical ApS
About this trial
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.
Eligibility criteria
Qualifiers
Subject must be 18 years of age or older
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.
Disqualifiers
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Subject with an invalid written informed consent or who has withdrawn consent.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 design
Treatments tested in this trial
- 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
Treatment groups
95 Participants
are divided into 1 treatment groupSponsors and collaborators
Radiometer Medical ApS
Lead sponsor
Bispebjerg Hospital
Collaborator
Source ClinicalTrials.gov