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

March 14, 2025 updated by: University Health Network, Toronto
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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

15000

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

  • Name: Deep Grewal

Study Contact Backup

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing cardiac surgery with cardiopulmonary bypass at Toronto General Hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

- Did not undergo viscoelastic testing during surgery

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac surgery patients
Adult patients undergoing cardiac surgery on cardiopulmonary bypass at Toronto General Hospital
Other: No intervention (observational study)
This is an observational study. No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Excessive bleeding
Time Frame: From the end of bypass to the end of postoperative day-1 (POD1)
Measured by the universal definition of perioperative bleeding (UDPB) scale
From the end of bypass to the end of postoperative day-1 (POD1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transfusion rate
Time Frame: 1) From time of entry to operating room (OR) to the end of post-operative day-1 (POD1) and post-operative day-7(POD7). 2) from end of cardiopulmonary bypass (CPB) to the end of post-operative day-1 (POD1) and post-operative day-7 (POD7)
Incidence and amount of transfusion of allogeneic blood products and factor concentrates
1) From time of entry to operating room (OR) to the end of post-operative day-1 (POD1) and post-operative day-7(POD7). 2) from end of cardiopulmonary bypass (CPB) to the end of post-operative day-1 (POD1) and post-operative day-7 (POD7)

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Keyvan Karkouti, University Health Network, Toronto

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 (Estimated)

March 15, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24-5983

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

product manufactured in and exported from the U.S.

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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