Thrombin in Cardiac Surgery

Coagulation Disorder Clinical Trial

Official title:

Diagnosis and Management of Impaired Thrombin Generation in Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04762576
• Other study ID #: 20-5726
• Status: Recruiting
• Start date: August 10, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: November 2022
• Source: University Health Network, Toronto
• Contact: Justyna Bartoszko, MD MSc FRCPC
• Phone: 416-340-4800
• Email: justyna.bartoszko[@]uhn.ca
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Blood Loss, Surgical
• Cardiovascular Surgical Procedures
• Coagulation Disorder
• Disease
• Hemostatic Disorder
• Hemostatic Disorders
• Surgical Blood Loss
• Thrombin

Locations

Country	Name	City	State
Canada	Toronto General Hospital - University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

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