Feasibility Performance Study of ABL90 FLEX PLUS HEM (ABL90FLEXHEM)

Radiometer

Status: Enrolling

Conditions: Hemolysis

Treatments: Diagnostic Test: 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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07345091

DC-089793-ABL90FLEX-HEM-Rev3

Details and patient eligibility

About

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.

Full description

The study is designed to assess the feasibility and performance of the ABL90 FLEX PLUS HEM device in a clinical environment. It will involve testing whole blood samples using the device and comparing results against established reference method. The primary focus is on validating the device's performance of the hemolysis detection function. The study will be conducted at one selected clinical site with trained personnel and will follow a predefined protocol to ensure consistency and reliability of data collection. The outcomes will inform future clinical studies aimed at supporting regulatory submissions and clinical adoption.

Enrollment: 95 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Subject with an invalid written informed consent or who has withdrawn consent.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.

Trial design

95 participants in 1 patient group

Adults, 18 years of age or older, that have been admitted to hospital and undergo blood collection

Description:

Adults, 18 years of age or older, that have been admitted to the hospital and undergo blood collection as part of their standard care will be eligible for participation. Many of these patients are admitted to the Intensive Care Unit (ICU) with acute injury or critical illness and are temporarily unconscious or sedated at the time of admission or during recovery in the intermediate care unit and post-anesthesia care unit due to their medical condition and required treatment (e.g., mechanical ventilation or sedation) and have an A- and or a V-line established for routine sample collection without additional burden as part of their standard care.

Treatment:

Diagnostic Test: 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