Thrombin in Cardiac Surgery
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Details and patient eligibility
About
Coagulopathy, bleeding, and transfusion are common in cardiac surgical patients. Our collaborator has developed a novel point of care device that can be used to assess thrombin generation in real-time in cardiac surgical patients. The investigators will measure thrombin generation using our novel device and compare it to standard methods, while examining the association of thrombin parameters with bleeding and other clinical outcomes.
Full description
This is a prospective observational cohort study of 200 cardiac surgical patients. Thrombin generation via our novel point of care thrombin generation assay as well as calibrated automated thrombography (CAT) will be measured at three time points: (1) before surgery; (2) post-CPB after heparin reversal with protamine; (3) at the time of chest closure or 60 minutes after heparin reversal with protamine. Clinicians will remain blinded to the measures. Recruitment will continue until the investigators enroll 50 patients with significant impaired thrombin generation capacity (>50% drop from baseline) and 50 patients who receive hemostatic therapies. Patients will be followed for 7 days postoperatively to assess individual products transfused.
Enrollment
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Volunteers
Inclusion criteria
-All adult patients (> 18 years of age) undergoing cardiac surgery at Toronto General Hospital will be offered participation.
Exclusion criteria
-Patients who are unable to consent to the study or who refuse participation will be excluded.
Trial design
200 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Justyna Bartoszko, MD MSc FRCPC
Data sourced from clinicaltrials.gov
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