Quantra Point-of-Care Hemostasis Monitoring

Description

The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion).

Conditions

Bleeding, Hemostatic Disorder

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Study Overview

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Study Details

Study overview

The investigators will test the hypothesis that utilization of a blood and blood component transfusion algorithm guided by the POC Quantra QPlus System in patients undergoing complex cardiac surgery will reduce RBC, plasma, cryoprecipitate, and platelet transfusion during surgery and the first 12 postoperative hours, compared to standard of care (central laboratory transfusion monitoring at the primary anesthesia provider's discretion).

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

Quantra Point-of-Care Hemostasis Monitoring

Condition
Bleeding
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 \[ECMO\], or percutaneous left ventricular assist device)
  • 1. Preoperative diagnosis of a pre-existing coagulation or bleeding disorder
  • 2. Preoperative abnormal coagulation disorder (aPTT\>40 seconds in the absence of heparin therapy and/or platelet count below 100,000/uL)
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Andra Duncan, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2026-12-31