ThrombinNCT04762576
Thrombin in Cardiac Surgery
An observational study of Thrombin and Hemostatic Disorder, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Coagulopathy, bleeding, and transfusion are common in cardiac surgical patients. Our collaborator has developed a novel point of care device that can be used to assess thrombin generation in real-time in cardiac surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombin, Hemostatic Disorder, Surgical Blood Loss
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 10 Aug 2022to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients with cardiovascular disease undergoing cardiac surgical procedures at Toronto General Hospital.
Who may be able to join
- -All adult patients (> 18 years of age) undergoing cardiac surgery at Toronto General Hospital will be offered participation.
Who cannot join
- -Patients who are unable to consent to the study or who refuse participation will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital - University Health Network
Toronto, Ontario, M5G 2C4
Justyna Bartoszko, MD MSc FRCPC, 416-340-4800 ext. 3243, justyna.bartoszko@uhn.ca
About this study
Official title: Diagnosis and Management of Impaired Thrombin Generation in Cardiac Surgery
Coagulopathy, bleeding, and transfusion are common in cardiac surgical patients. Our collaborator has developed a novel point of care device that can be used to assess thrombin generation in real-time in cardiac surgical patients. The investigators will measure thrombin generation using our novel device and compare it to standard methods, while examining the association of thrombin parameters with bleeding and other clinical outcomes.
Read the detailed description
This is a prospective observational cohort study of 200 cardiac surgical patients. Thrombin generation via our novel point of care thrombin generation assay as well as calibrated automated thrombography (CAT) will be measured at three time points: (1) before surgery; (2) post-CPB after heparin reversal with protamine; (3) at the time of chest closure or 60 minutes after heparin reversal with protamine. Clinicians will remain blinded to the measures. Recruitment will continue until the investigators enroll 50 patients with significant impaired thrombin generation capacity (>50% drop from baseline) and 50 patients who receive hemostatic therapies. Patients will be followed for 7 days postoperatively to assess individual products transfused.
- Conditions
- Thrombin, Hemostatic Disorder, Surgical Blood Loss, Coagulation Disorder, Cardiovascular Surgical Procedures
- Medical subject headings
- Hemostatic Disorders, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgical Patients | All consenting adults undergoing cardiac surgery at Toronto General Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombin Generation, as assessed by the Endogenous Thrombin Potential (ETP)
The primary thrombin generation parameter of interest is the endogenous thrombin potential, or ETP, expressed in nM*min. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
Measured: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
Thrombin Generation, as assessed by the Lag Time
The co-primary thrombin generation parameter of interest is the Lag Time, expressed in seconds. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
Measured: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
Thrombin Generation, as assessed by the Time to Peak
The co-primary thrombin generation parameter of interest is the Time to Peak, expressed in seconds. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
Measured: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
Thrombin Generation, as assessed by the Peak Height
The co-primary thrombin generation parameter of interest is the Peak Height, expressed in nM. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
Measured: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
Secondary outcomes (5)
Total Units of Red Blood Cells Transfused
The total number of red blood cells units transfused will be recorded
Measured: From intra-operatively up to 12 hours post-operatively
Total Units of Platelets Transfused
The total number of platelets units transfused will be recorded
Measured: From intra-operatively up to 12 hours post-operatively
Total Units of Frozen Plasma Transfused
The total number of frozen plasma units transfused will be recorded
Measured: From intra-operatively up to 12 hours post-operatively
Total amount of Prothrombin Complex Concentrates transfused
The total number of prothrombin complex concentrate units will be recorded
Measured: From intra-operatively up to 12 hours post-operatively
Total amount of Fibrinogen Concentrate transfused
The total number of grams of fibrinogen concentrate transfused will be recorded
Measured: From intra-operatively up to 12 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start10 Aug 2022
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombinStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Justyna Bartoszko, MD MSc FRCPC, Principal investigator, Toronto General Hospital - University Health NetworkKeyvan Karkouti, MD MSc FRCPC, Principal investigator, Toronto General Hospital - University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762576
- Sponsor's protocol ID
- 20-5726
- Status last verified
- Nov 2022
- First submitted
- 2 Feb 2021
- Last updated
- 9 Nov 2022
- 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 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Management of Impaired Thrombin Generation in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04762576
- Acronym / sponsor ID
- 20-5726
- Conditions
- Thrombin, Hemostatic Disorder, Surgical Blood Loss, Coagulation Disorder, Cardiovascular Surgical Procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 21 Feb 2021 (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.
Coagulopathy, bleeding, and transfusion are common in cardiac surgical patients. Our collaborator has developed a novel point of care device that can be used to assess thrombin generation in real-time in cardiac surgical patients. The investigators will measure thrombin generation using our novel device and compare it to standard methods, while examining the association of thrombin parameters with bleeding and other clinical outcomes.
Detailed description
This is a prospective observational cohort study of 200 cardiac surgical patients. Thrombin generation via our novel point of care thrombin generation assay as well as calibrated automated thrombography (CAT) will be measured at three time points: (1) before surgery; (2) post-CPB after heparin reversal with protamine; (3) at the time of chest closure or 60 minutes after heparin reversal with protamine. Clinicians will remain blinded to the measures. Recruitment will continue until the investigators enroll 50 patients with significant impaired thrombin generation capacity (>50% drop from baseline) and 50 patients who receive hemostatic therapies. Patients will be followed for 7 days postoperatively to assess individual products transfused.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgical Patients | – | –All consenting adults undergoing cardiac surgery 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
- Adult patients with cardiovascular disease undergoing cardiac surgical procedures at Toronto General Hospital.
Key inclusion criteria (1 listed)
- -All adult patients (> 18 years of age) undergoing cardiac surgery at Toronto General Hospital will be offered participation.
Key exclusion criteria (1 listed)
- -Patients who are unable to consent to the study or who refuse participation will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thrombin Generation, as assessed by the Endogenous Thrombin Potential (ETP)
Time frame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
The primary thrombin generation parameter of interest is the endogenous thrombin potential, or ETP, expressed in nM*min. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
Thrombin Generation, as assessed by the Lag Time
Time frame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
The co-primary thrombin generation parameter of interest is the Lag Time, expressed in seconds. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
Thrombin Generation, as assessed by the Time to Peak
Time frame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
The co-primary thrombin generation parameter of interest is the Time to Peak, expressed in seconds. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
Thrombin Generation, as assessed by the Peak Height
Time frame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively
The co-primary thrombin generation parameter of interest is the Peak Height, expressed in nM. The change in thrombin generation in patients undergoing cardiac surgery before and after cardiopulmonary bypass using our new point-of-care thrombin sensor and the established laboratory-based calibrated automated thrombogram (CAT) assay will be assessed.
5 secondary outcomes
Total Units of Red Blood Cells Transfused
Time frame: From intra-operatively up to 12 hours post-operatively
Total Units of Platelets Transfused
Time frame: From intra-operatively up to 12 hours post-operatively
Total Units of Frozen Plasma Transfused
Time frame: From intra-operatively up to 12 hours post-operatively
Total amount of Prothrombin Complex Concentrates transfused
Time frame: From intra-operatively up to 12 hours post-operatively
Total amount of Fibrinogen Concentrate transfused
Time frame: From intra-operatively up to 12 hours post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Justyna Bartoszko, MD MSc FRCPC principal investigator
Toronto General Hospital - University Health Network
Keyvan Karkouti, MD MSc FRCPC principal investigator
Toronto General Hospital - University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombin and Hemostatic Disorder, run by University Health Network, Toronto at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justyna Bartoszko, MD MSc FRCPC (416-340-4800 ext. 3243, justyna.bartoszko@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombin Generation, as assessed by the Endogenous Thrombin Potential (ETP) (time frame: The change in thrombin generation will be assessed from preoperative baseline up until 12 hours post-operatively). The study lists 4 primary outcomes in all. 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 9 Nov 2022.