Protamine Sulfate During Transcatheter Aortic Valve Implantation (PS TAVI)
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|ClinicalTrials.gov Identifier: NCT02974660|
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Stenosis||Drug: Protamine sulfate Drug: 0.9% NaCl||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Use of Protamine Sulfate During Transcatheter Aortic Valve Implantation - Impact on Bleeding and Thromboembolic Complications|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||January 2019|
Active Comparator: Protamine sulfate
After obtaining optimal valve deployment patients will receive protamine sulfate (1 mg for each 100 units of UFH i.v.). Measurement of activated clotting time (ACT) will be performed (after heparin administration and after protamine sulfate administration).
Drug: Protamine sulfate
Placebo Comparator: 0.9% NaCl
After obtaining optimal valve deployment patients will receive 0.9% saline (20 ml i.v.). Measurement of activated clotting time (ACT) will be performed (after heparin administration and after placebo administration).
Drug: 0.9% NaCl
- Bleeding complications [ Time Frame: 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])
- Successful closure of the access-site [ Time Frame: 15 minutes ]Angiographic assessment of contrast extravasation from the access site after closure with preclose device at the end of the procedure. Unit of measure: 0/1 (absence/presence).
- Thromboembolic complications [ Time Frame: 5 days or hospital discharge, whichever occurs first ]Clinical assessment of thromboembolic complications in the central nervous system and peripheral vasculature (e.g. mesenteric, extremities). Unit of measure: 0/1 (absence/presence)
- Assessment of peri-procedural myocardial muscle injury [ Time Frame: 24 hours ]Measurements of levels of high sensitivity cardiac troponin T and isoenzyme MB of creatine kinase before the procedure and 6- and 12-24 hours after the procedure. Unit of measure: high sensitivity cardiac troponin T [ng/L], isoenzyme MB of creatine kinase [mcg/L].
- All-cause mortality [ Time Frame: 30 days ]All-cause mortality. Unit of measure: 0/1 (absence/presence).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974660
|Contact: Karol Zbroński, MDfirstname.lastname@example.org|
|Contact: Zenon Huczek, MD PhDemail@example.com|
|First Department of Cardiology, Medical University of Warsaw||Recruiting|
|Contact: Karol Zbronski, MD 0048607516810 firstname.lastname@example.org|
|Contact: Zenon Huczek, MD PhD email@example.com|