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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized heparin and protamine titration | Active Comparator | 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). |
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| Activated Clotting Time guided heparin and protamine dose | Active Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemostasis Management System Plus | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eleni Argiriadou, Dr | Associate Professor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aristotle University of Thessaloniki | Thessaloniki | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37776194 | Derived | Gkiouliava A, Argiriadou H, Antonitsis P, Goulas A, Papapostolou E, Sarridou D, Karapanagiotidis GT, Anastasiadis K. Individualized heparin monitoring and management reduces protamine requirements in cardiac surgery on minimal invasive extracorporeal circulation; A prospective randomized study. Perfusion. 2024 Nov;39(8):1595-1604. doi: 10.1177/02676591231204284. Epub 2023 Sep 30. |
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| Activated Coagulation Timer System Plus | Device | The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds. |
|
| 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 |