HEParin Antagonisation in Transcatheter Aortic Valve Implantation
- Conditions
- Transcatheter Aortic Valve ImplantationProtamine Sulfate OverdoseAortic Valve Stenosis
- Registration Number
- NCT05422170
- Lead Sponsor
- Deutsches Herzzentrum Muenchen
- Brief Summary
Unfractioned heparin is usually given in a defined dosage during transfemoral TAVI. Activated Clotting Time (ACT) is usually used to measure the heparin effect. ACT-analysis is easy to perform at the bedside, but susceptible to interference effects. At the end of the procedure, protamine is given to reverse eventual residual heparin effect. An overdose of protamine can impair the coagulation itself. The investigators want to analyse the effect of a partial heparin reversal by ROTEM Analysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Severe aortic valve Stenosis
- transfemoral TAVI as best therapy option
- unfractioned heparin for periprocedural anticoagulation
Exclusion Criteria
- known hypersensitivity /allergy to unfractioned heparin or protamine
- acute systemic infection
- pre procedural started and ongoing intravenous therapy with unfractioned heparin
- severe periprocedural adverse event with the need for emergency surgery (with or with our CPB)
- refusal of the patient to participate
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint Periprocedural Variability of the ROTEM CT(INTEM) after partial heparin reversal
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München
🇩🇪Munich, Bavaria, Germany