Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Percent of samples correctly classified into hemolysis bins (0-4) using ABL90 FLEX PLUS HEM hemolysis flag
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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- •Subject with an invalid written informed consent or who has withdrawn consent.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.
研究组 & 干预措施
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.
干预措施: 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)
结局指标
主要结局
Percent of samples correctly classified into hemolysis bins (0-4) using ABL90 FLEX PLUS HEM hemolysis flag
时间窗: At time of sample analysis (single session per sample; Day 1)
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.
次要结局
- 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))