Loading clinical trials...
Loading clinical trials...
Diagnosis and Management of Impaired Thrombin Generation in Cardiac Surgery
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Toronto General Hospital - University Health Network
Toronto, Ontario, Canada
Start Date
August 10, 2022
Primary Completion Date
January 1, 2023
Completion Date
January 1, 2023
Last Updated
November 9, 2022
200
ESTIMATED participants
Lead Sponsor
University Health Network, Toronto
Collaborators
NCT06096116
NCT07276074
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04918173