Anticoagulation Management in Complex Cardiac Surgery

Study Overview
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Brief Summary
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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: 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.

Official Title
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Impact on Anticoagulation Management When Activated Clotting Time is Combined With Heparin Concentration Monitoring in Cardiac Surgery: a Randomised Clinical Trial

Conditions
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Extracorporeal Circulation

Intervention / Treatment
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* Other: Activated Clotting Time measurements combined with heparin concentration monitoring
* Other: Activated Clotting Time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective procedures cardiac surgery, except for Coronary Artery Bypass Grafting Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation Exclusion Criteria: known allergy to heparin or protamine hematological disease

Ages Eligible for Study
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Minimum Age: 18 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Activated Clotting Time (ACT)<br>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 | Other: Activated Clotting Time<br>* 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.<br>|
| Active Comparator: Heparin Concentration (HC)<br>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: Heparin Dose Response test Heparin Assay test | Other: Activated Clotting Time measurements combined with heparin concentration monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Platelet count | Platelet count per mm^3 | 48 hours after surgery | 

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