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| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-45 minutes after t=0 measurement (within one sample session; Day 1) |
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Inclusion Criteria:
Subject must be 18 years of age or older
Informed consent is obtained:
Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.
Exclusion Criteria:
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Adults, 18 years of age or older, that have been admitted to the hospital and undergo blood collection as part of their standard care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vadim Fedulov | Contact | +4526311594 | vadim.fedulov@radiometer.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bispebjerg Hospital | Recruiting | Copenhagen | NV | 2400 | Denmark |
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| ID | Term |
|---|---|
| D006461 | Hemolysis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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). | 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 | 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). | During RMED manipulation session (baseline to after 2 aspiration rounds; Day 1) |
| 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. | At time of native sample analysis (Day 1) |