Cardiopulmonary Bypass
Conditions
Keywords
anticoagulation, cardiopulmonary bypass
Brief summary
During a cardiac surgery under cardiopulmonary bypass it is essential that an appropriate level of anticoagulation is accomplished. To achieve this, the patient is administered heparin. After completion of the surgery, protamine is given to reverse the anticoagulant action of heparin. In this prospective clinical study the researchers will investigate the impact of the two different methods to calculate the required dosage of heparin and protamine; the individualized calculation computed by the Hemostasis Management System Plus (HMS Plus, Medtronic, Minneapolis, MN) device and the weight based. The investigators hypothesize that the aforementioned methods result in different dosages and will elaborate on their impact on postoperative bleeding.
Interventions
DEVICEHemostasis Management System Plus
Hemostasis Management System Plus (Medtronic, Minneapolis, MN) is a point of care device useful in the management of heparinization during bypass. It estimates the individual heparin dose response and calculates heparin concentration (IU/ml) in whole blood.
DEVICEActivated Coagulation Timer System Plus
The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds.
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent * elective cardiac surgery under cardiopulmonary bypass
Exclusion criteria
* known blood disorder * contraindication to heparin administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total heparin dose | operation duration | Heparin dose measured in IU |
| Total protamine dose | At the end of the cardiopulmonary bypass | Protamine dose measured in mg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Red Blood Cells transfusion | intraoperatively | Red Blood Cells transfusion measured in units |
| Fibrinogen concentrate transfusion | intraoperatively | Fibrinogen concentrate transfusion measured in g |
| Prothrombin Complex Concentrate transfusion | intraoperatively | Prothrombin Complex Concentrate transfusion measured in IU |
| Platelets transfusion | intraoperatively | Platelet transfusion measured in units |
Countries
Greece
Outcome results
None listed