Feasibility Performance Study of ABL90 FLEX PLUS HEM

Официальное название

Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Percent of samples correctly classified into hemolysis bins (0-4) using ABL90 FLEX PLUS HEM hemolysis flag [Срок оценки: At time of sample analysis (single session per sample; Day 1)]

Вторичные конечные точки (4)

• Slope of change in ccfHb concentration over 0-45 minutes (mg/dL per minute) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: During RMED manipulation session (baseline to after 2 aspiration rounds; Day 1)]
• Percentage of native whole blood samples with hemolysis (ccfHb > 20 mg/dL) [Срок оценки: At time of native sample analysis (Day 1)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Экологическое

Центры проведения

Дания · 1 центр

• Bispebjerg Hospital — Copenhagen

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗