Clinical trial NCT04762576: Thrombin in Cardiac Surgery
Official title: Diagnosis and Management of Impaired Thrombin Generation in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombin
Hemostatic Disorder
Surgical Blood Loss
Coagulation Disorder
Cardiovascular Surgical Procedures
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2021-02-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with cardiovascular disease undergoing cardiac surgical procedures at Toronto General Hospital.

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.

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 (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.

Eligibility 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.

Primary outcomes:
measure: Thrombin Generation, as assessed by the Endogenous Thrombin Potential (ETP)
timeFrame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
measure: Thrombin Generation, as assessed by the Lag Time
timeFrame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
measure: Thrombin Generation, as assessed by the Time to Peak
timeFrame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
measure: Thrombin Generation, as assessed by the Peak Height
timeFrame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
Secondary outcomes:
measure: Total Units of Red Blood Cells Transfused
timeFrame: From intra-operatively up to 12 hours post-operatively
measure: Total Units of Platelets Transfused
timeFrame: From intra-operatively up to 12 hours post-operatively
measure: Total Units of Frozen Plasma Transfused
timeFrame: From intra-operatively up to 12 hours post-operatively
measure: Total amount of Prothrombin Complex Concentrates transfused
timeFrame: From intra-operatively up to 12 hours post-operatively
measure: Total amount of Fibrinogen Concentrate transfused
timeFrame: From intra-operatively up to 12 hours post-operatively
Other outcomes:
measure: Chest tube drainage
timeFrame: From intra-operatively to within 12 hours post-operatively
measure: Return to the Operating Room for Bleeding or Delayed Chest Closure
timeFrame: From intra-operatively to within 12 hours post-operatively
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital - University Health Network
state: Ontario
Study officials:
affiliation: Toronto General Hospital - University Health Network
name: Justyna Bartoszko, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto General Hospital - University Health Network
name: Keyvan Karkouti, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References: