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

Not yet recruiting

• Conditions: Cardiac Surgery Requiring Cardiopulmonary Bypass

• Registration Number: NCT06882759
• Lead Sponsor: University Health Network, Toronto

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study Start: 2025-03-15
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-03-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Excessive bleeding	From the end of bypass to the end of postoperative day-1 (POD1)	Measured by the universal definition of perioperative bleeding (UDPB) scale

Secondary Outcome Measures

Name	Time	Method
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)	Incidence and amount of transfusion of allogeneic blood products and factor concentrates