Thrombin in Cardiac Surgery

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04762576
Study type	Observational
Source	University Health Network, Toronto
Contact	Justyna Bartoszko, MD MSc FRCPC
Phone	416-340-4800
Email	justyna.bartoszko@uhn.ca
Status	Recruiting
Phase
Start date	August 10, 2022
Completion date	January 1, 2023

View Details

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