Bleeding Clinical Trial
— QUANTRAOfficial title:
Quantra Point-of-Care Hemostasis Monitoring and Perioperative Blood and Blood Component Transfusion During High-Risk Complex Cardiac Surgery: A Randomized Clinical Trial
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).
Status | Not yet recruiting |
Enrollment | 666 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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], or percutaneous left ventricular assist device) Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | PT/aPTT | Postoperative PT/aPTT measurement at 1 hour (±1 hr) after surgery end. | 1 Hour after surgery end | |
Other | INR | Postoperative INR measurement at 1 hour (±1 hr) after surgery end. | 1 hour after surgery end | |
Other | Platelet | Postoperative platelet count measurement at 1 hour (±1 hr) after surgery end. | 1 hour after surgery end | |
Other | Fibrinogen | Postoperative fibrinogen measurement at 1 hour (±1 hr) after surgery end. | 1 hour after surgery end | |
Other | hematocrit/hemoglobin | Postoperative hematocrit/hemoglobin measured at 1 hour (±1 hr) after surgery end. | 1 hour after surgery end | |
Other | ICU length of stay | ICU length of stay | During hospitalization, an average of 30 days. | |
Other | Hospital length of stay. | Hospital length of stay. | During hospitalization, an average of 30 days. | |
Other | In-hospital mortality | In-hospital mortality | During hospitalization | |
Primary | Blood and blood component transfusions | 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. | 12 hours after ICU arrival | |
Secondary | Bleeding | Postoperative bleeding assessed by the Universal Definition of perioperative bleeding during index hospitalization, which classification into categories 0 - 4 based upon the following complications related to perioperative bleeding: the assessment of delayed sternal closure; amount of postoperative chest tube blood loss within 12 hours; Units of PRBC, FFP, platelets, and cryoprecipitate; need for PCCs or rFVIIa, or re-exploration/tamponade. | During hospitalization, up to 24 hours |
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