Status:
COMPLETED
Thrombin Generation During Cardiopulmonary Bypass With Titrated Versus Conventional Anticoagulation Management.
Lead Sponsor:
University Health Network, Toronto
Conditions:
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In this study, the investigators will be comparing anticoagulation for Cardiopulmonary Bypass (CPB) guided by the Hemostasis Management System (HMS Plus) with the current dosing based on weight and AC...
Detailed Description
Cardiopulmonary bypass (CPB) allows cardiac surgery to be performed on a motionless, bloodless heart while maintaining circulation to the rest of the body. Anticoagulation with heparin prevents the bo...
Eligibility Criteria
Inclusion
- Scheduled to undergo non-emergent coronary artery bypass grafting, valve repair or replacement (with or without ascending aortic replacement) or a combination of these procedures requiring the use of CPB
Exclusion
- Less than 18 years old
- Planned use of deep hypothermic circulatory arrest
- Cases where use of brief circulatory arrest anticipated
- Highly complex cases (LVAD, Heart Transplant, Complex congenital)
- Significant liver dysfunction (liver enzymes \> 2-fold higher than upper limit of normal
- Pre-existing coagulopathy (INR \>1.5, PTT \>45 seconds, fibrinogen \< 1.0g/L, platelet count \<100x109/L)
- Use of long acting oral anticoagulants
- Patients on heparin infusions pre-operatively
- Major hemoglobinopathies, thalassemia or iron storage diseases
- Previous diagnosis of HIT
- Lack of informed consent
Key Trial Info
Start Date :
October 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03347201
Start Date
October 2 2017
End Date
May 28 2019
Last Update
December 24 2020
Active Locations (1)
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1
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada, M5G 2C4