CClinicalTrials.gg
Not yet recruitingNCT06882759Updated Mar 19, 2025

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

An observational study in Cardiac Surgery Requiring Cardiopulmonary Bypass, sponsored by University Health Network, Toronto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by University Health Network, Toronto · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
15,000
Ages
18 Years and older
Sex
All
01

Study 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?

02

Conditions studied

  • Cardiac Surgery Requiring Cardiopulmonary Bypass

Keywords

  • cardiac surgery
  • viscoelastic testing
  • point-of-care
  • ROTEM
  • cardiopulmonary bypass
  • bleeding
03

In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing cardiac surgery with cardiopulmonary bypass at Toronto General Hospital

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Did not undergo viscoelastic testing during surgery
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
15,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Cardiac surgery patients

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

    Other: No intervention (observational study)

Interventions

  • OtherNo intervention (observational study)

    This is an observational study. No intervention.

06

What researchers measure

Primary outcomes

  1. Excessive bleeding

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

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

Secondary outcomes

  1. Transfusion rate

    Incidence and amount of transfusion of allogeneic blood products and factor concentrates

    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)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06882759
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Mar 19, 2025
Start date
Mar 15, 2025 (estimated)
Primary completion
Mar 15, 2026 (estimated)
Completion
Mar 15, 2026 (estimated)
Last update
Mar 19, 2025

Study contacts

Keyvan Karkouti
Contact
keyvan.karkouti@uhn.ca
416-340-4800 ext. 8597
Deep Grewal
Contact
Keyvan Karkouti
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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