Quantra Point-of-Care Hemostasis Monitoring

Launched by THE CLEVELAND CLINIC · Mar 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to monitor blood transfusions during complex heart surgeries. Researchers want to see if using a special device called the Quantra QPlus System can help doctors make better decisions about when to give patients blood products, such as red blood cells and plasma. The goal is to reduce the amount of blood transfusions needed during surgery and in the first 12 hours after surgery compared to the usual method, which relies on doctors' judgment without the aid of the device.

To participate in this trial, you need to be at least 18 years old and scheduled for certain high-risk heart surgeries, like aortic surgery or surgeries that require heart-lung machines. However, you cannot have pre-existing bleeding disorders, severe liver disease, or be pregnant or breastfeeding. If you join the trial, you can expect to receive monitoring with the Quantra QPlus System during your surgery, which may help improve your care. If you have any questions or concerns about participating, the research team will be available to help you understand everything.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults aged 18 years or more
• • 2. Scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary bypass (high-risk surgery includes reoperative surgery, active endocarditis, expected need for intraoperative circulatory arrest, radiation heart disease, end-stage kidney disease requiring renal replacement therapy, combination surgery including more than one valve or valve plus CABG, low left ventricular ejection fraction \[EF\<30%\] with potential need for mechanical circulatory support with intra-aortic balloon pump, extracorporeal membrane oxygenation \[ECMO\], pulmonary thromboembolectomy or percutaneous left ventricular assist device (VAD), and planned placement of a durable left VAD with or without placement of RV assist device.
• Exclusion Criteria:
• • 1. Preoperative diagnosis of a pre-existing coagulation or bleeding disorder
• • 2. Preoperative abnormal coagulation disorder (platelet count below 100,000/uL and/or aPTT \>40 seconds in the absence of heparin therapy. Prolonged aPTT \>40 seconds in the acceptable if due to heparin therapy.)
• • 3. Liver disease, defined as a history of cirrhosis, liver enzymes \>3x normal range or manifested by elevated PT suggesting abnormal liver synthetic function not explained by other comorbidities
• • 4. Pregnancy or breastfeeding
• • 5. Refusal to accept red blood cells and blood component transfusions.
• • 6. Contraindications to proposed interventions.
• • 7. Unable to understand English as a first language or unable comprehend the study and/or the consent forms.
• • 8. Vulnerable patients including prisoners, human fetuses, and neonates