Quantra Point-of-Care Hemostasis Monitoring

Last updated: March 11, 2025
Sponsor: The Cleveland Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombocytopenic

Blood Clots

Treatment

POC Quantra QPlus System

Routine care

Clinical Study ID

NCT06328647
24-010
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adults aged 18 years or more

  2. Scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonarybypass (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 surgeryincluding more than one valve or valve plus CABG, low left ventricular ejectionfraction [EF<30%] with potential need for mechanical circulatory support withintra-aortic balloon pump, extracorporeal membrane oxygenation [ECMO], pulmonarythromboembolectomy or percutaneous left ventricular assist device (VAD), and plannedplacement of a durable left VAD with or without placement of RV assist device.

Exclusion

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/oraPTT >40 seconds in the absence of heparin therapy. Prolonged aPTT >40 seconds inthe acceptable if due to heparin therapy.)

  3. Liver disease, defined as a history of cirrhosis, liver enzymes >3x normal range ormanifested by elevated PT suggesting abnormal liver synthetic function not explainedby 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 studyand/or the consent forms.

  8. Vulnerable patients including prisoners, human fetuses, and neonates

Study Design

Total Participants: 666
Treatment Group(s): 2
Primary Treatment: POC Quantra QPlus System
Phase:
Study Start date:
October 03, 2024
Estimated Completion Date:
December 31, 2026

Study Description

The Investigators propose a randomized control trial to assess patients scheduled for aortic surgery or high-risk cardiac surgery requiring cardiopulmonary bypass.

Patients will be randomized 1:1 to routine care or POC Quantra QPlus System. The total number of blood and blood component transfusions (including RBC, plasma, cryoprecipitate, and platelets) during and after cardiac surgery until 12 hours after ICU arrival will be analyzed between the groups.

Connect with a study center

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

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