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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

This trial does not accept healthy volunteers

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Subject with an invalid written informed consent or who has withdrawn consent.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

Trial design

Design model

Ecologic or community

Time perspective

Prospective

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

    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.

Treatment groups

95 Participants
are divided into 1 treatment group
Group A: Adults, 18 years of age or older, that have been admitted to hospital and undergo blood collection1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

For each sample, ccfHb is measured on ABL90 FLEX PLUS HEM at t=0, 15, 30, and 45 minutes (±5 minutes). The outcome is the slope (mg/dL/min) from linear regression of ccfHb versus time over 0-45 minutes.

Time frame
0-45 minutes after t=0 measurement (within one sample session; Day 1)
2

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

Paired measurements are obtained from the same sample: ABL90 FLEX PLUS HEM measures ccfHb (mg/dL) in S65 mode, and Roche cobas 8000 reports Hemolysis Index (HI) using the hemolysis index assay. The outcome is the Pearson correlation coefficient (r) across paired ABL90 ccfHb and Cobas HI values (unitless r).

Time frame
At time of paired analysis per sample (Day 1)
3

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

For each sample, ABL90 FLEX PLUS HEM measures ccfHb and potassium (cK+) at baseline (no manipulation), after 1 round of RMED aspiration manipulation, and after 2 rounds. The outcome is Pearson correlation coefficient (r) between ccfHb and potassium values pooled across the three measurements (unitless r).

Time frame
During RMED manipulation session (baseline to after 2 aspiration rounds; Day 1)
4

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

Among native (non-contrived) leftover arterial and venous whole blood samples, the outcome is the percentage of samples with ccfHb \> 20 mg/dL as measured on ABL90 FLEX PLUS HEM.

Time frame
At time of native sample analysis (Day 1)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Radiometer Medical ApS

Lead sponsor

Bispebjerg Hospital

Collaborator

Source ClinicalTrials.gov
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