Aristotle University of Thessaloniki
Thessaloniki, Greece
NCT Number: NCT04215588
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.
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Notify Me18 year–79 year
All sexes
Interventional
Not applicable
Thessaloniki, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds.
Time frame: operation duration
Heparin dose measured in IU
Time frame: At the end of the cardiopulmonary bypass
Protamine dose measured in mg
Time frame: intraoperatively
Red Blood Cells transfusion measured in units
Time frame: 24 hours after the end of the operation
Red Blood Cells transfusion measured in units
Time frame: intraoperatively
Fibrinogen concentrate transfusion measured in g
Time frame: 24 hours after the end of the operation
Fibrinogen concentrate transfusion measured in g
Time frame: intraoperatively
Prothrombin Complex Concentrate transfusion measured in IU
Time frame: 24 hours after the end of the operation
Prothrombin Complex Concentrate transfusion measured in IU
Time frame: intraoperatively
Platelet transfusion measured in units
Time frame: 24 hours after the end of the operation
Platelet transfusion measured in units
Aristotle University Of Thessaloniki
Other
Heparin and Protamine Titration Using Optical Detection Technology in Patients Undergoing Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation
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