Phase
Condition
Thrombocytopenic
Blood Clots
Treatment
POC Quantra QPlus System
Routine care
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adults aged 18 years or more
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:
Preoperative diagnosis of a pre-existing coagulation or bleeding disorder
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.)
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
Pregnancy or breastfeeding
Refusal to accept red blood cells and blood component transfusions.
Contraindications to proposed interventions.
Unable to understand English as a first language or unable comprehend the studyand/or the consent forms.
Vulnerable patients including prisoners, human fetuses, and neonates
Study Design
Study Description
Connect with a study center
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United StatesActive - Recruiting
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