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

NCT06882759 | Not Yet Recruiting

• 1 other identifier: 24-5983
• Study Type: observational
• Target: 15,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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?

Conditions

Cardiac Surgery Requiring Cardiopulmonary Bypass

Keywords

cardiac surgery; viscoelastic testing; point-of-care; ROTEM; cardiopulmonary bypass; bleeding

Outcome Measures

Primary Outcomes (1)

• Excessive bleeding

  Measured by the universal definition of perioperative bleeding (UDPB) scale

  From the end of bypass to the end of postoperative day-1 (POD1)

Secondary Outcomes (1)

• Transfusion rate

  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)

Study Arms (1)

Cardiac surgery patients

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

Other: No intervention (observational study)

Interventions

No intervention (observational study) OTHER

This is an observational study. No intervention.

Cardiac surgery patients

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

Patients undergoing cardiac surgery with cardiopulmonary bypass at Toronto General Hospital

You may qualify if:

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

You may not qualify if:

• \- Did not undergo viscoelastic testing during surgery

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Hemorrhage

Interventions

Observation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Keyvan Karkouti

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keyvan Karkouti

CONTACT

416-340-4800; keyvan.karkouti@uhn.ca

Deep Grewal

CONTACT

Study Design

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

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 19, 2025
• Study Start: March 15, 2025
• Primary Completion: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share