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Thrombin in Cardiac Surgery

NCT ID: NCT04762576

Last Updated: 2022-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-10

Study Completion Date

2023-01-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Thrombin Hemostatic Disorder Surgical Blood Loss Coagulation Disorder Cardiovascular Surgical Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Surgical Patients

All consenting adults undergoing cardiac surgery at Toronto General Hospital.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justyna Bartoszko, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital - University Health Network

Keyvan Karkouti, MD MSc FRCPC

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital - University Health Network

Locations

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Toronto General Hospital - University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Justyna Bartoszko, MD MSc FRCPC

Role: CONTACT

[email protected]
416-340-4800 ext. 3243

Facility Contacts

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Justyna Bartoszko, MD MSc FRCPC

Role: primary

[email protected]
416-340-4800 ext. 3243

Other Identifiers

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20-5726

Identifier Type: -

Identifier Source: org_study_id

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