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The goal of this clinical trial is to compare the anticoagulation management with or without heparin concentration level guidance, in patients undergoing valve or complex cardiac surgery during cardiopulmonary bypass using closed, coated circuits. The main questions it aims to answer are:
Participants are adult patients scheduled for valve or complex cardiac surgery. They are randomised to either Activated Clotting Time guided management alone or combined with heparin level concentration monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activated Clotting Time (ACT) | Active Comparator | In this group, only ACT measurements and fixed doses of heparin and protamine are administered. ACT is measured using the ACT Plus device (Medtronic, MN, USA). Heparin formulation administered is HEPARIN/LEO INJ.SOL 25000IU/5ML. Protamine formulation administered is PROTAMINE SULPHATE/LEO PHARMA 10mg/ml |
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| Heparin Concentration (HC) | Active Comparator | In this group, the Hepcon HMS Plus (Medtronic, MN, USA) is used to perform heparin concentration calculations and test each patient's individual response to heparin. Specifically tests performed were:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated Clotting Time measurements combined with heparin concentration monitoring | Other | In the HC group, the initial heparin dose is calculated using the HepCon HMS Plus . Except for ACT, heparin concentration is measured to maintain target heparin levels during CPB. The protamine dose for reversal is computed based on actual measured heparin levels using the device. ACT is also performed in all instances. |
| Measure | Description | Time Frame |
|---|---|---|
| Heparin dose | Heparin dose, IU | Bolus dose before cardiopulmonary bypass |
| Heparin dose | Heparin dose, IU | Total dose after cardiopulmonary bypass |
| Protamine dose | Protamine dose, mg | Total dose after cardiopulmonary bypass |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet count | Platelet count per mm^3 | Immediately after surgery |
| Platelet count | Platelet count per mm^3 | 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helena Argiriadou, Dr | AHEPA University Hospital, Aristotole University of Thessaloniki | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AHEPA University Hospital, Aristotle University of Thessaloniki | Thessaloniki | 54124 | Greece |
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| Activated Clotting Time | Other | The target ACT for procedures other than Coronary Artery Bypass Grafting (CABG) is 400s when Minimally Invasive Extracorporeal Circulation is used. A bolus of 300 International Units(IU)/kg heparin are administered to reach this target and initiate cardiopulmonary bypass (CPB). Repeated ACT measurements guide further heparin dose to maintain adequate anticoagulation. Then, at the end of the CPB, 0.75 mg of protamine are administered for every 100IU of the initial heparin bolus. |
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| Platelet count | Platelet count per mm^3 | 48 hours after surgery |