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Recruiting NCT07345091

Feasibility Performance Study of ABL90 FLEX PLUS HEM

— Observational Hemolysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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.
Who it may be relevant to
Registry conditions: Hemolysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM

Overview

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.

Detailed 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.

Interventions

  • 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
    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.

Primary outcome measures

  • Percent of samples correctly classified into hemolysis bins (0-4) using ABL90 FLEX PLUS HEM hemolysis flag [Time frame: At time of sample analysis (single session per sample; Day 1)]
Secondary outcome measures (4)
  • Slope of change in ccfHb concentration over 0-45 minutes (mg/dL per minute) [Time frame: 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) [Time frame: 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 [Time frame: During RMED manipulation session (baseline to after 2 aspiration rounds; Day 1)]
  • Percentage of native whole blood samples with hemolysis (ccfHb > 20 mg/dL) [Time frame: At time of native sample analysis (Day 1)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Ecologic or community

Study locations

Denmark · 1 center
  • Bispebjerg Hospital — Copenhagen

Identifiers

NCT: NCT07345091 · DC-089793-ABL90FLEX-HEM-Rev3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗