Thrombin in Cardiac Surgery

November 4, 2022 updated by: University Health Network, Toronto

Diagnosis and Management of Impaired Thrombin Generation in Cardiac Surgery

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital - University Health Network
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cardiac Surgical Patients
All consenting adults undergoing cardiac surgery at Toronto General Hospital.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Thrombin Generation, as assessed by the Endogenous Thrombin Potential (ETP)
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Units of Red Blood Cells Transfused
Time Frame: From intra-operatively up to 12 hours post-operatively
The total number of red blood cells units transfused will be recorded
From intra-operatively up to 12 hours post-operatively
Total Units of Platelets Transfused
Time Frame: From intra-operatively up to 12 hours post-operatively
The total number of platelets units transfused will be recorded
From intra-operatively up to 12 hours post-operatively
Total Units of Frozen Plasma Transfused
Time Frame: From intra-operatively up to 12 hours post-operatively
The total number of frozen plasma units transfused will be recorded
From intra-operatively up to 12 hours post-operatively
Total amount of Prothrombin Complex Concentrates transfused
Time Frame: From intra-operatively up to 12 hours post-operatively
The total number of prothrombin complex concentrate units will be recorded
From intra-operatively up to 12 hours post-operatively
Total amount of Fibrinogen Concentrate transfused
Time Frame: From intra-operatively up to 12 hours post-operatively
The total number of grams of fibrinogen concentrate transfused will be recorded
From intra-operatively up to 12 hours post-operatively

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Chest tube drainage
Time Frame: From intra-operatively to within 12 hours post-operatively
Blood loss from chest tube drainage will be assessed in mL
From intra-operatively to within 12 hours post-operatively
Return to the Operating Room for Bleeding or Delayed Chest Closure
Time Frame: 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
From intra-operatively to within 12 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-5726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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