Aortic Valve Stenosis, Protamine Sulfate Overdose, Transcatheter Aortic Valve Implantation
Conditions
Keywords
Anticoagulation
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.
Interventions
None listed
Sponsors
Deutsches Herzzentrum Muenchen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint | Periprocedural | Variability of the ROTEM CT(INTEM) after partial heparin reversal |
Countries
Germany
Contacts
Primary ContactPatrick Mayr, MD
Backup ContactMichael Joner, Prof
Outcome results
None listed