Protamine Sulfate During Transcatheter Aortic Valve Implantation
Status:
Completed
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
Summary
Transcatheter aortic valve implantation (TAVI) is a new, rapidly emerging standard of care in
inoperable and high-risk patients with severe, symptomatic aortic stenosis. Information
regarding reversal of unfractionated heparin with protamine sulfate in order to facilitate
access site closure is scarce and based on expert consensus. Clinical practice varies between
centers. Protamine sulphate may decrease the amount of bleeding complications related to the
access-site. The impact on possible thromboembolic complications is unknown. Both bleeding
and thromboembolic complications increase mortality after TAVI. A randomized trial is
required in order to assess impact of protamine sulfate on prevalence and extent of bleeding
and thromboembolic complications.