Clinical Study for Validation of the Hemocue Plasma Free Hb System in Ecmo and Vad Whole Blood Samples from Pediatric and Adult Population.
Study for Measuring Plasma Free Hemoglobin in ECMO and VAD Patients
Michelle Zimmerman, MD
Primary Investigator
Brief description of study
The purpose of this research is to validate the HemoCue Plasma Free Hb System for measuring plasma free hemoglobin (PfHb) in blood samples from patients on Extra Corporeal Mechanical Oxygenation (ECMO) or ventricular assist device (VAD) support. This system aims to provide accurate and reliable measurements to monitor a condition called hemolysis, which is the breakdown of red blood cells in the blood.
Detailed description of study
The purpose of this study is to validate a new in vitro diagnostic medical device called the HemoCue Plasma Free Hb System (referred to as IVD medical device herein), for measuring a specific substance in blood called “plasma free hemoglobin (PfHb). Participation in this study will involve a single visit for blood sample collection. The total time required for sample collection will be less than 15 mins. The treating physician will draw 10 mL of additional blood in tandem with SOC samples. The sample will be provided to our research staff for processing and testing. Testing data will be provided to the sponsor for analysis and eventual submission to the FDA.
This clinical research study will be conducted in a minimum of three sites across the US, and a minimum of 100 whole blood samples from subjects on ECMO and VAD will be collected and measured on the IVD medical device by the intended users who are laboratory personnel, specialized nurses and other health professionals.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Respiratory failure, Cardiac failure, Acute respiratory distress syndrome, ARDS
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Age: 100 years or below
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Gender: All
Patient Inclusion Criteria:
• Subjects requiring mechanical circulatory support of either:
- Extracorporeal membrane oxygenation support (ECMO) including V-A, V-V
and V-A-V circuits.
- Ventricular assist devices (VAD), including Long-term durable VADs
(LVAD) and percutaneous ventricular assist devices (pVAD) using an axial
flow pump (e.g. Impella, TandemHeart) including pulsatile-flow and
continuous-flow VADs. VAD population will be adult only.
• Ability to obtain written consent from subject or legally authorized representative
• Subjects from whom adequate blood sample volume can be drawn
(children/adolescents/adult patients: minimum 10 mL whole blood, and neonates (0-28
days) /infants (29 days - 2 years): minimum 6 mL whole blood).
Patient Exclusion Criteria:
• Subjects with conditions considered by their healthcare provider to put them at increased
health risk if providing blood sample.
• Subjects whose maximum blood draw volume based on weight is already reached
(especially for neonates and infants).
• Subjects for whom an informed consent or assent cannot be completed
• Judgment by the investigator that the participant should not participate in the study per
medical conditions.
This study investigates the validation of an investigational medical device for measuring plasma free hemoglobin in patients using ECMO or VAD life-support machines. Plasma free hemoglobin is a substance that indicates hemolysis, which is the breakdown of red blood cells. The purpose of this study is to ensure the device can accurately and reliably measure this substance in blood samples from both children and adults.
Participants in this study will have a single visit where a blood sample will be taken. The process involves collecting 10 mL of blood alongside routine care samples, which will take less than 15 minutes. The samples will be processed and tested by laboratory personnel, specialized nurses, and other health professionals. The data collected will be analyzed and submitted to the FDA.
- Who can participate: Patients using ECMO or VAD support, including adults and children, are eligible. Written consent must be provided by participants or their representatives.
- Study details: Participants will have a single visit for blood collection, where 10 mL of blood will be drawn. The samples will be used to test the investigational device's accuracy in measuring plasma free hemoglobin.
- Study visits: The study requires 1 visit.
