Interruptions in the Coagulationsystem in Relation With Cardiac Surgery - A Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to find the heparinization method, which affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis gives the smallest change in endogenous thrombin potential (ETP)postoperative compared to preoperative (deltaETP) as an indicator for haemostatic activation during cardiac surgery. The hypothesis is that the deltaETP is larger in the Haemochron Signature Elite group than in the Hepcon-group because of the heparinization-method. Therefore there is a potential higher risk for use of bloodproducts postoperatively.

Official Title
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Interruptions in the Coagulationsystem in Relation With Cardiac Surgery -A Randomized Study Comparing Two Heparinization Strategies During On-pump Cardiac Surgery

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Device: Activated clotting time versus blood-heparin concentration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective on-pump coronary artery bypass grafting (CABG) single procedure Elective aortavalve replacement (AVR) (single procedure) Exclusion Criteria: Emergency procedures Children and youngsters less than 18 years Pregnancy Less than 2 days break with platelet inhibiting drugs (acetylsalicylic acid, NSAID, clopidogrel, serotonin reuptake inhibitors) Less than 2 days break with AC-treatment (warfarin, heparin, coumarin etc) Known coagulopathy Endocarditis Preoperative anaemia Dialysis patients

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Activated clotting time (ACT) group<br>heparinization measured as activated clotting time during surgery | Device: Activated clotting time versus blood-heparin concentration<br>* Activated clotting time used for heparinization strategy during cardiag surgery versus blood-heparin concentration<br>* Other names: HMS;|
| Experimental: Hepcon group<br>heparinization measured as heparin concentration in the blood during surgery | Device: Activated clotting time versus blood-heparin concentration<br>* Activated clotting time used for heparinization strategy during cardiag surgery versus blood-heparin concentration<br>* Other names: HMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta Thrombingeneration | Postoperative versus preoperative thrombingeneration evaluated by Endogenous Thrombin Potential,peak Thrombin level and Lagtime by using a Thromboscope | Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peroperative heparine/protaminesulphate ratio |  | The timeframe is from the first heparin is given to the neutralization with protamine sulfate, average time 4 hours | 
| Platelet function | Platelet aggregation measured by Multiplate platelet function analyzer | Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. | 
| Thromboelastometry | We are looking at the parameters: Clottingtime, Clot formation time and maximum velocity,maximum clot firmness | Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. | 
| Standard coagulationtests |  | Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heparin treatment during cardiac surgery, Heparin reversal after cardiac surgery, Thrombin generation, Endogenous Thrombin potential