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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06882759
Enrollment
15000
Registered
2025-03-19
Start date
2025-03-15
Completion date
2026-03-15
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery Requiring Cardiopulmonary Bypass

Keywords

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

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?

Interventions

OTHERNo intervention (observational study)

This is an observational study. No intervention.

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- Did not undergo viscoelastic testing during surgery

Design outcomes

Primary

MeasureTime frameDescription
Excessive bleedingFrom the end of bypass to the end of postoperative day-1 (POD1)Measured by the universal definition of perioperative bleeding (UDPB) scale

Secondary

MeasureTime frameDescription
Transfusion rate1) 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

Contacts

Primary ContactKeyvan Karkouti
keyvan.karkouti@uhn.ca416-340-4800
Backup ContactDeep Grewal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026