Cardiac Surgery
Conditions
Keywords
Heparin treatment during cardiac surgery, Heparin reversal after cardiac surgery, Thrombin generation, Endogenous Thrombin potential
Brief summary
The purpose of this study is to find the heparinization method, which 1. affect the heparin-protaminsulfate ratio in the best way to achieve haemostasis 2. 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.
Interventions
DEVICEActivated clotting time versus blood-heparin concentration
Activated clotting time used for heparinization strategy during cardiag surgery versus blood-heparin concentration
Sponsors
Medtronic
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delta Thrombingeneration | Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. | Postoperative versus preoperative thrombingeneration evaluated by Endogenous Thrombin Potential,peak Thrombin level and Lagtime by using a Thromboscope |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Platelet function | Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. | Platelet aggregation measured by Multiplate platelet function analyzer |
| peroperative heparine/protaminesulphate ratio | The timeframe is from the first heparin is given to the neutralization with protamine sulfate, average time 4 hours | — |
| Thromboelastometry | Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. | We are looking at the parameters: Clottingtime, Clot formation time and maximum velocity,maximum clot firmness |
| Standard coagulationtests | Timeframe is from Start of surgery to 4 hours after end of surgery, average time 9 hours. | — |
Countries
Denmark
Outcome results
None listed