Two Monitors for Measuring the Activated Clotting Time: A Comparison

Study Overview
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Brief Summary
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In this observational study a comparison is made between two different monitors for measurement of the activated clotting time (ACT): mechanical versus biochemical techniques

Detailed Description
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The ACT is a functional test influenced by multiple factors, such as platelet function, coagulation factors, temperature and contact activation inhibitors. Results produced by different monitors are also prone to vary influenced by the specific method employed to perform the test. The present clinical study aims to compare two types of ACT monitors: the Hemostatic Management System Plus (Medtronic) and i-STAT (Abbott) in 20 cardiac surgical patients by performing five intraoperative consecutive measurements using anti factor Xa as a reference for the actual heparin concentration. Inclusion criteria comprised patients aged 20-80 years, scheduled for coronary bypass surgery. Measurements: 1) before induction of anaesthesia 2 ) after heparin bolus 3) rewarming of the patient 4) weaning from cardiopulmonary bypass 5) after protamine administration. The Hemostatic System Plus ACT monitor served as reference for dosing of heparin in all patients. The study protocol did not intervene with the standard protocol used for anticoagulation. No patient interventions were made. It is hypothesised that the i-STAT ACT monitor has a better correlation with the actual heparin concentration than the Hemostatic Management System Plus

Official Title
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Comparison of Two Point of Care Techniques Mechanical Versus Biochemical Activated Clotting Time

Conditions
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Cardiopulmonary Bypass, Blood Coagulation, Point-of-Care Testing

Intervention / Treatment
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* Diagnostic Test: Point-of-Care ACT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients listed for coronary bypass surgery, - Exclusion Criteria: Primary coagulation disorder, diabetes mellitus, ongoing anti-coagulation therapy, emergency, reduced kidney function, allergy for fish, sea food and protamine -

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CABG Surgical Patients<br>Patients undergoing coronary bypass grafting with cardiopulmonary bypass | Diagnostic Test: Point-of-Care ACT<br>* Comparison between two point-of-care devices for measurement of the activated clotting time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activated Clotting time | Coagulation Measure | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Factor Xa | Reference for heparin plasma concentration | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Bypass, Blood Coagulation Testing, Point-of-Care Testing