Relationship of Point-of-care Coagulation Assays with Clinical Outcomes in Cardiac Surgery: a Retrospective Cohort Study

NCT ID: NCT06882759

Last Updated: 2025-03-19

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

NOT_YET_RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-15

Study Completion Date

2026-03-15

Brief Summary

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The goal of this observational study is to determine the relationship of ROTEM point-of-care coagulation assay parameters with excessive bleeding and clinical outcomes in patients undergoing cardiac surgery at Toronto General Hospital. The main questions it aims to answer are: i) How well does viscoelastic testing (VET) predict the clinical outcome of excessive bleeding in cardiac surgery? ii) Which VET parameters have the greatest accuracy for identification of patients who will have excessive bleeding? iii) 3) What is the prognostic value of abnormal VET parameters with other clinical outcomes after cardiac surgery?

Detailed Description

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Conditions

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Cardiac Surgery Requiring Cardiopulmonary Bypass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cardiac surgery patients

Adult patients undergoing cardiac surgery on cardiopulmonary bypass at Toronto General Hospital

No intervention (observational study)

Intervention Type OTHER

This is an observational study. No intervention.

Interventions

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No intervention (observational study)

This is an observational study. No intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients ≥ 18 years old
* Underwent a cardiac surgical procedure with cardiopulmonary bypass

Exclusion Criteria

\- Did not undergo viscoelastic testing during surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keyvan Karkouti

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Central Contacts

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Keyvan Karkouti

Role: CONTACT

416-340-4800 ext. 8597

Deep Grewal

Role: CONTACT

Other Identifiers

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24-5983

Identifier Type: -

Identifier Source: org_study_id

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