Thrombin in Cardiac Surgery
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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 will be measured at four time points: (1) before surgery; (2) before CPB initiation; (3) post-CPB after reversal of heparin; (4) and after chest closure before leaving the operating room. 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 12 hours postoperatively to assess for bleeding outcomes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cardiac Surgical Patients All consenting adults undergoing cardiac surgery at Toronto General Hospital. |
Outcome Measures
Primary Outcome Measures
- Thrombin Generation, as assessed by the Endogenous Thrombin Potential (ETP) [The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively]
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.
- Thrombin Generation, as assessed by the Lag Time [The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively]
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.
- Thrombin Generation, as assessed by the Time to Peak [The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively]
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.
- Thrombin Generation, as assessed by the Peak Height [The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively]
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.
Secondary Outcome Measures
- Total Units of Red Blood Cells Transfused [From intra-operatively up to 12 hours post-operatively]
The total number of red blood cells units transfused will be recorded
- Total Units of Platelets Transfused [From intra-operatively up to 12 hours post-operatively]
The total number of platelets units transfused will be recorded
- Total Units of Frozen Plasma Transfused [From intra-operatively up to 12 hours post-operatively]
The total number of frozen plasma units transfused will be recorded
- Total amount of Prothrombin Complex Concentrates transfused [From intra-operatively up to 12 hours post-operatively]
The total number of prothrombin complex concentrate units will be recorded
- Total amount of Fibrinogen Concentrate transfused [From intra-operatively up to 12 hours post-operatively]
The total number of grams of fibrinogen concentrate transfused will be recorded
Other Outcome Measures
- Chest tube drainage [From intra-operatively to within 12 hours post-operatively]
Blood loss from chest tube drainage will be assessed in mL
- Return to the Operating Room for Bleeding or Delayed Chest Closure [From intra-operatively to within 12 hours post-operatively]
Instances of return to the operating room for re-exploration or a delay in chest closure will be assessed
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Toronto General Hospital - University Health Network | Toronto | Ontario | Canada | M5G 2C4 |
Sponsors and Collaborators
- University Health Network, Toronto
- McMaster University
Investigators
- Principal Investigator: Justyna Bartoszko, MD MSc FRCPC, Toronto General Hospital - University Health Network
- Principal Investigator: Keyvan Karkouti, MD MSc FRCPC, Toronto General Hospital - University Health Network
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-5726