Who is sponsoring PS TAVI?

PS TAVI is sponsored by Medical University of Warsaw.

What condition does PS TAVI study?

PS TAVI studies Aortic Valve Stenosis.

What drugs are being tested in PS TAVI?

Interventions: Protamine sulfate, 0.9% NaCl.

What is the status of PS TAVI?

PS TAVI is currently COMPLETED.

Last reviewed 2020-10-21 · How we verify

Use of Protamine Sulfate During Transcatheter Aortic Valve Implantation - Impact on Bleeding and Thromboembolic Complications (PS TAVI)

NCT02974660 Phase 4 COMPLETED

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.

Details

Lead sponsor	Medical University of Warsaw
Phase	Phase 4
Status	COMPLETED
Enrolment	100
Start date	2016-12
Completion	2020-09

Conditions

Aortic Valve Stenosis

Interventions

Protamine sulfate
0.9% NaCl

Primary outcomes

Bleeding complications — 48 hours or hospital discharge, whichever occurs first
Composite of life-threatening and major bleeding complications according to Valve Academic Research Consortium (VARC) criteria (unit of measure: 0/1 \[absence/presence\])

Countries

Poland