Postoperative Hemorrhage
Conditions
Keywords
heparin management
Brief summary
Study has been completed and is in the data analysis and manuscript writing phase of the project.
Interventions
DRUGHeparin
300u/kg of heparin for CPB ACT performed. If ACT is \< 480 seconds a bolus of 5000u heparin will be given. ACT will be repeated and bolus given until ACT is\>480 seconds
DRUGHH or high heparin
initial dose of 450u/kg for CPB ACT performed additional bolus given if result is \<600 seconds anytime during CPB
DRUGheparin concentration HC
will have anticoagulation during CPB assessed with heparin concentration monitoring and heparin dose response (HDR) to determine the optimal dosage of heparin. This group will evaluate the possible benefit of the HDR to determine heparin dosing and monitoring to achieve maximal suppression of thrombin compared to a fixed dose of heparin as the other two groups. Additional heparin doses will be given to maintain a specific heparin concentration according to the HDR. This is a recognized way of managing heparin dosing and anticoagulation for CPB. All three groups will have heparin neutralized by protamine. Adequacy of heparin neutralization will be based on a difference between the ACT and heparinase-treated ACT values of less than 10%
Sponsors
Medtronic
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Adult male and non-pregnant female patients scheduled for elective cardiac surgery requiring CPB will be eligible for enrollment.
Exclusion criteria
* Age less than 18 or greater than 90 years; emergency surgery * Circulatory arrest * Combined non-cardiac procedures such as carotid endarterectomy * Congenital heart repair * Off-CPB coronary artery bypass grafting (CABG) * Clotting disorder * Fibrinolytic agents (e.g. streptokinase), severe hepatic disease * Aprotinin use * Cooling \< 28 degrees C during CPB * Dialysis dependent renal failure; and * Platelet receptor GP3a/2b antagonists medication received within 48 hours of surgery. Patients that are not receiving tranexamic acid (TA) intraoperatively will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| measure blood loss | within 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| transfusion requirements | 48 hours |
Countries
United States
Outcome results
None listed