Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM Device to Evaluate Hemolysis Detection in Hospitalized Adults

What this Trial Is About

Researchers are evaluating the ABL90 FLEX PLUS HEM device for its ability to detect hemolysis in blood samples within a clinical setting. The study focuses on assessing the device's analytical performance, particularly the hemolysis detection feature, by comparing its results to established reference methods. This feasibility performance study aims to gather data that will support future clinical trials and regulatory approval processes. The study involves testing whole blood samples from adults admitted to the hospital, many of whom are critically ill and may be unconscious or sedated. Blood samples are collected as part of standard care, often through existing arterial or venous lines, without adding extra burden to the patient. The device's hemolysis detection function is being assessed during these routine blood collections at a single clinical site with trained personnel following a strict protocol. Participants will have their blood samples analyzed once per session to measure hemolysis levels, with outcomes including the percentage of samples correctly classified into hemolysis categories. Additional measurements include changes in hemoglobin concentration over time and correlations with established hemolysis indices and potassium levels. The study ensures informed consent from participants or their legal representatives and monitors safety by excluding those for whom sample collection poses unnecessary risk. The total study duration and participant involvement are aligned with routine hospital care procedures.

Feasibility Performance Study of ABL90 FLEX PLUS HEM