Cardiac Surgery Requiring Cardiopulmonary BypassNCT06882759
Relationship of Point-of-care Coagulation Assays with Clinical Outcomes in Cardiac Surgery: a Retrospective Cohort Study
An observational study of Cardiac Surgery Requiring Cardiopulmonary Bypass, run by University Health Network, Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Requiring Cardiopulmonary Bypass
- How many people
- 15,000 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 15 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery with cardiopulmonary bypass at Toronto General Hospital
Who may be able to join
- Adult patients ≥ 18 years old
- Underwent a cardiac surgical procedure with cardiopulmonary bypass
Who cannot join
- Did not undergo viscoelastic testing during surgery
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Deep Grewal contact
About this 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?
- Being tested
- No intervention (observational study)
- Keywords
- cardiac surgery, viscoelastic testing, point-of-care, ROTEM, cardiopulmonary bypass, bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
This is an observational study. No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery patients | Adult patients undergoing cardiac surgery on cardiopulmonary bypass at Toronto General Hospital Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excessive bleeding
Measured by the universal definition of perioperative bleeding (UDPB) scale
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Requiring Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keyvan Karkouti, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882759
- Sponsor's protocol ID
- 24-5983
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Point-of-care Coagulation Assays with Clinical Outcomes in Cardiac Surgery: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06882759
- Acronym / sponsor ID
- 24-5983
- Keywords
- cardiac surgery, viscoelastic testing, point-of-care, ROTEM, cardiopulmonary bypass, bleeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Mar 2026 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery patients | – | Other: No intervention (observational study)Adult patients undergoing cardiac surgery on cardiopulmonary bypass at Toronto General Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery with cardiopulmonary bypass at Toronto General Hospital
Key inclusion criteria (2 listed)
- Adult patients ≥ 18 years old
- Underwent a cardiac surgical procedure with cardiopulmonary bypass
Key exclusion criteria (1 listed)
- Did not undergo viscoelastic testing during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)This is an observational study. No intervention. | Other | Cardiac surgery patients |
Primary outcome
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
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Cardiac Surgery Requiring Cardiopulmonary Bypass
Not yet recruiting
BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine
Cerebral Autoregulation Impairment, Postoperative Cognitive Dysfunction
Active, not recruiting
SIRAKI 02 Posthoc Analysis.
Cardiac Surgery Requiring Cardiopulmonary Bypass, Acute Kidney Injury
RecruitingPhase 3
Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass
Nitric Oxide, Cardiac Surgery
Not yet recruitingObservational study
The Association Between Tau & GFAP and Postoperative Neurological Impairment in Patients Undergoing Cardiac Surgery
Cardiac Surgery Requiring Cardiopulmonary Bypass, Brain Injury
RecruitingObservational study
A Comparison of Renal vs Limb NIRS for Predicting Cardiac Surgery Associated Acute Kidney Injury
NIRS, Cardiac Surgery Associated - Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deep Grewal contact
Keyvan Karkouti principal investigator
University Health Network, Toronto
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery Requiring Cardiopulmonary Bypass, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keyvan Karkouti (416-340-4800 ext. 8597, keyvan.karkouti@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excessive bleeding (time frame: From the end of bypass to the end of postoperative day-1 (POD1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.