Heparin and Protamine Titration in Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation

Study Overview
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Brief Summary
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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.

Official Title
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Heparin and Protamine Titration Using Optical Detection Technology in Patients Undergoing Cardiac Surgery Under Minimal Invasive Extracorporeal Circulation

Conditions
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Cardiopulmonary Bypass

Intervention / Treatment
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* Device: Hemostasis Management System Plus
* Device: Activated Coagulation Timer System Plus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent elective cardiac surgery under cardiopulmonary bypass Exclusion Criteria: known blood disorder contraindication to heparin administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Individualized heparin and protamine titration<br>The device Hemostasis Management System Plus (Medtronic, Minneapolis, MN) will be used to determine the patients' sensitivity to heparin and its concentration in whole blood. Then, it will automatically calculate the necessary dose for anticoagulation during bypass. The protamine dose to eliminate heparin effect will be calculated from the remaining heparin concentration (0.75mg/100 International Units circulating heparin). | Device: Hemostasis Management System Plus<br>* 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.<br>|
| Active Comparator: Activated Clotting Time guided heparin and protamine dose<br>Heparin initial dose will be determined according to the patients' weight to achieve a required Activated Clotting Time (ACT) to initiate cardiopulmonary bypass. Subsequent doses of heparin will be administered according to ACT and protamine dose will be calculated from total heparin dose (0.75mg protamine/100 International Units heparin) | Device: Activated Coagulation Timer System Plus<br>* The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total heparin dose | Heparin dose measured in IU | operation duration | 
| Total protamine dose | Protamine dose measured in mg | At the end of the cardiopulmonary bypass | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red Blood Cells transfusion | Red Blood Cells transfusion measured in units | intraoperatively | 
| Red Blood Cells transfusion | Red Blood Cells transfusion measured in units | 24 hours after the end of the operation | 
| Fibrinogen concentrate transfusion | Fibrinogen concentrate transfusion measured in g | intraoperatively | 
| Fibrinogen concentrate transfusion | Fibrinogen concentrate transfusion measured in g | 24 hours after the end of the operation | 
| Prothrombin Complex Concentrate transfusion | Prothrombin Complex Concentrate transfusion measured in IU | intraoperatively | 
| Prothrombin Complex Concentrate transfusion | Prothrombin Complex Concentrate transfusion measured in IU | 24 hours after the end of the operation | 
| Platelets transfusion | Platelet transfusion measured in units | intraoperatively | 
| Platelets transfusion | Platelet transfusion measured in units | 24 hours after the end of the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anticoagulation, cardiopulmonary bypass