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

ConditionCardiac Surgery Requiring Cardiopulmonary Bypass

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity Health Network, Toronto

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients ≥ 18 years old

Underwent a cardiac surgical procedure with cardiopulmonary bypass

Disqualifiers

None

Trial population

Patients undergoing cardiac surgery with cardiopulmonary bypass at Toronto General Hospital

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

No intervention (observational study)
Other intervention
This is an observational study. No intervention.

Treatment groups

15,000 Participants

are divided into 1 treatment group

Group A: Cardiac surgery patients1 intervention

Trial outcomes

Primary outcomes

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

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)

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: