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: * initial heparin bolus, subsequent supplementary doses and total heparin variance among groups. * protamine dose among groups. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
65
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.
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.
AHEPA University Hospital, Aristotle University of Thessaloniki
Thessaloniki, Greece
Heparin dose
Heparin dose, IU
Time frame: Bolus dose before cardiopulmonary bypass
Heparin dose
Heparin dose, IU
Time frame: Total dose after cardiopulmonary bypass
Protamine dose
Protamine dose, mg
Time frame: Total dose after cardiopulmonary bypass
Platelet count
Platelet count per mm\^3
Time frame: Immediately after surgery
Platelet count
Platelet count per mm\^3
Time frame: 24 hours after surgery
Platelet count
Platelet count per mm\^3
Time frame: 48 hours after surgery
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