Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06882759

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

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?

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Cardiac Surgery Requiring Cardiopulmonary Bypass Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Did not undergo viscoelastic testing during surgery

Treatment and study plan

No intervention (observational study)

Other

This is an observational study. No intervention.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Deep Grewal

CONTACT

Keyvan Karkouti

CONTACT

[email protected]

416-340-4800 ext. 8597

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.