Monitoring blood clotting during complex heart surgeries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Andra Duncan, MD — The Cleveland Clinic
• Study coordinator: Stephanie Stoianoff, MBA
• Email: stoians@ccf.org
• Phone: 216 444-0231

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.