Feasibility Performance Study of ABL90 FLEX PLUS HEM

NCT07345091 | Recruiting FDA Device

• 1 other identifier: DC-089793-ABL90FLEX-HEM-Rev3
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemolysis

Keywords

IVDR; Blood Gas Analyser; In vitro diagnostic; hemolysis detection

Outcome Measures

Primary Outcomes (1)

• Percent of samples correctly classified into hemolysis bins (0-4) using ABL90 FLEX PLUS HEM hemolysis flag

  Whole blood samples (native and contrived) are classified into five hemolysis bins based on reference ccfHb (mg/dL): bin 0 (0-100), bin 1 (101-200), bin 2 (201-400), bin 3 (401-1000), bin 4 (\>1000). "Correct classification" is the proportion of samples where the ABL90 FLEX PLUS HEM hemolysis flag matches the reference bin assignment.

  At time of sample analysis (single session per sample; Day 1)

Secondary Outcomes (4)

• Slope of change in ccfHb concentration over 0-45 minutes (mg/dL per minute)

  0-45 minutes after t=0 measurement (within one sample session; Day 1)

• Pearson correlation coefficient (r) between ABL90 ccfHb (mg/dL) and Cobas 8000 Hemolysis Index (HI)

  At time of paired analysis per sample (Day 1)

• Pearson correlation coefficient (r) between ccfHb and potassium concentration (cK+, mmol/L) after RMED aspiration manipulation

  During RMED manipulation session (baseline to after 2 aspiration rounds; Day 1)

• Percentage of native whole blood samples with hemolysis (ccfHb > 20 mg/dL)

  At time of native sample analysis (Day 1)

Study Arms (1)

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

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.

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

Interventions

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 DIAGNOSTIC_TEST

The hemolysis detection function is a newly developed sample quality feature on the ABL90 FLEX PLUS HEM intended to detect hemolyzed samples and to improve the reliability of the results provided by blood gas analyzer.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults, 18 years of age or older, that have been admitted to the hospital and undergo blood collection as part of their standard care.

You may qualify if:

• 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
• Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radiometer Medical ApS: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen, NV, 2400, Denmark

RECRUITING

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Vadim Fedulov

CONTACT

+4526311594; vadim.fedulov@radiometer.dk

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: January 15, 2026
• Study Start: August 4, 2025
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): June 10, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)