NCT05422170

HEParin Antagonisation in Transcatheter Aortic Valve Implantation

Heparin Influence on Anticoagulation and Perioperative Hemostasis During Transfemoral Transcatheter Aortic Valve Implantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Transcatheter Aortic Valve Implantation
• Protamine Sulfate Overdose

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-01-31
• Completion: 2023-04-01
• First posted: 2022-06-16
• Last updated: 2022-07-05

Locations

1 site across 1 country: Germany