Thrombin in Cardiac Surgery

NCT04762576 | Unknown

• 1 other identifier: 20-5726
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombin; Hemostatic Disorder; Surgical Blood Loss; Coagulation Disorder; Cardiovascular Surgical Procedures

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Total Units of Red Blood Cells Transfused

  From intra-operatively up to 12 hours post-operatively

• Total Units of Platelets Transfused

  From intra-operatively up to 12 hours post-operatively

• Total Units of Frozen Plasma Transfused

  From intra-operatively up to 12 hours post-operatively

• Total amount of Prothrombin Complex Concentrates transfused

  From intra-operatively up to 12 hours post-operatively

• Total amount of Fibrinogen Concentrate transfused

  From intra-operatively up to 12 hours post-operatively

Other Outcomes (2)

• Chest tube drainage

  From intra-operatively to within 12 hours post-operatively

• Return to the Operating Room for Bleeding or Delayed Chest Closure

  From intra-operatively to within 12 hours post-operatively

Study Arms (1)

Cardiac Surgical Patients

All consenting adults undergoing cardiac surgery at Toronto General Hospital.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with cardiovascular disease undergoing cardiac surgical procedures at Toronto General Hospital.

You may qualify if:

• All adult patients (\> 18 years of age) undergoing cardiac surgery at Toronto General Hospital will be offered participation.

You may not qualify if:

• Patients who are unable to consent to the study or who refuse participation will be excluded.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• McMaster University: collaborator

Study Sites (1)

Toronto General Hospital - University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood samples will be retained for CAT analysis

MeSH Terms

Conditions

Hemostatic Disorders; Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Justyna Bartoszko, MD MSc FRCPC

  Toronto General Hospital - University Health Network

  PRINCIPAL INVESTIGATOR

• Keyvan Karkouti, MD MSc FRCPC

  Toronto General Hospital - University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justyna Bartoszko, MD MSc FRCPC

CONTACT

416-340-4800; justyna.bartoszko@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 21, 2021
• Study Start: August 10, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)