UnknownNot Applicable

HEParin Antagonisation in Transcatheter Aortic Valve Implantation

Germany50 participantsStarted 2022-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Primary endpoint

Timeframe: Periprocedural

Trial details

NCT IDNCT05422170

SponsorDeutsches Herzzentrum Muenchen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-31

Contact for this trial

Patrick Mayr, MD

+498912180 mayrp@dhm.mhn.de

View on ClinicalTrials.gov More Aortic Valve Stenosis trials