Monitoring blood clotting during complex heart surgeries

Quantra Point-of-Care Hemostasis Monitoring and Perioperative Blood and Blood Component Transfusion During High-Risk Complex Cardiac Surgery: A Randomized Clinical Trial

This study is testing whether a new blood monitoring system can help reduce the need for blood transfusions during and after complex heart surgeries.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 666 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Drugs / interventions: radiation
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06328647 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of the Quantra QPlus System for point-of-care hemostasis monitoring in patients undergoing complex cardiac surgeries. Participants will be randomly assigned to receive either standard care or the Quantra system, which guides blood transfusion decisions. The study will measure the total number of blood component transfusions required during surgery and the first 12 hours postoperatively. By comparing the two groups, the trial seeks to determine if the Quantra system can reduce the need for transfusions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older scheduled for high-risk cardiac surgeries requiring cardiopulmonary bypass.

Not a fit: Patients with pre-existing coagulation or bleeding disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to reduced blood transfusions during and after cardiac surgery, improving patient outcomes and safety.

How similar studies have performed: Other studies have shown promise in using point-of-care monitoring for transfusion management, suggesting potential success for this approach.

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

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic Foundation — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Andra Duncan, MD — The Cleveland Clinic
• Study coordinator: Stephanie Stoianoff, MBA

Conditions: Bleeding, Hemostatic Disorder