Coagulation Disorder Clinical Trial
Official title:
Diagnosis and Management of Impaired Thrombin Generation in Cardiac Surgery
NCT number | NCT04762576 |
Other study ID # | 20-5726 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 10, 2022 |
Est. completion date | January 1, 2023 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | January 1, 2023 |
Est. primary completion date | January 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital - University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | McMaster University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Chest tube drainage | Blood loss from chest tube drainage will be assessed in mL | From intra-operatively to within 12 hours post-operatively | |
Other | Return to the Operating Room for Bleeding or Delayed Chest Closure | Instances of return to the operating room for re-exploration or a delay in chest closure will be assessed | From intra-operatively to within 12 hours post-operatively | |
Primary | Thrombin Generation, as assessed by the Endogenous Thrombin Potential (ETP) | The primary thrombin generation parameter of interest is the endogenous thrombin potential, or ETP, expressed in nM*min. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed. | The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively | |
Primary | Thrombin Generation, as assessed by the Lag Time | The co-primary thrombin generation parameter of interest is the Lag Time, expressed in seconds. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed. | The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively | |
Primary | Thrombin Generation, as assessed by the Time to Peak | The co-primary thrombin generation parameter of interest is the Time to Peak, expressed in seconds. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed. | The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively | |
Primary | Thrombin Generation, as assessed by the Peak Height | The co-primary thrombin generation parameter of interest is the Peak Height, expressed in nM. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed. | The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively | |
Secondary | Total Units of Red Blood Cells Transfused | The total number of red blood cells units transfused will be recorded | From intra-operatively up to 12 hours post-operatively | |
Secondary | Total Units of Platelets Transfused | The total number of platelets units transfused will be recorded | From intra-operatively up to 12 hours post-operatively | |
Secondary | Total Units of Frozen Plasma Transfused | The total number of frozen plasma units transfused will be recorded | From intra-operatively up to 12 hours post-operatively | |
Secondary | Total amount of Prothrombin Complex Concentrates transfused | The total number of prothrombin complex concentrate units will be recorded | From intra-operatively up to 12 hours post-operatively | |
Secondary | Total amount of Fibrinogen Concentrate transfused | The total number of grams of fibrinogen concentrate transfused will be recorded | From intra-operatively up to 12 hours post-operatively |
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