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Two HEmostasis Methods After TransradIal Catheterization: THEMATIC - protocol for a randomized clinical trial

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Title: Two HEmostasis Methods After TransradIal Catheterization: THEMATIC - protocol for a randomized clinical trial
Authors: Santos, Simone Marques dos, Rabelo-Silva, Eneida Rejane, Aliti, Graziella Badin, Romero, Paola Severo, Corrêa, Camille Lacerda, Valle, Felipe Homem, Gonçalves, Sandro Cadaval, Wainstein, Marco Vugman, Wainstein, Rodrigo Vugman
Source: Revista Gaúcha de Enfermagem. January 2018 39
Publisher Information: Universidade Federal do Rio Grande do Sul. Escola de Enfermagem, 2018.
Publication Year: 2018
Subject Terms: Randomized controlled trial, Cardiac catheterization/adverse effects, Radial artery, Hemostatic techniques
More Details: OBJECTIVE Randomized clinical trial protocol to evaluate the incidence of radial artery occlusion with two different arterial compression devices after transradial procedures. METHODS Barbeau’s test will be performed in adults scheduled to undergo transradial interventional procedures. Those with A, B, or C plethysmographic patterns will be selected. At the end of the procedure, patients will be randomly assigned (1:1) to receive patent haemostasis with TR Band™ device or conventional haemostasis with an elastic adhesive bandage. The primary outcome is the incidence of radial artery occlusion. Secondary outcomes are Barbeau’s test curve change, additional time to achieve haemostasis, incidence of bleeding at the puncture site, pain severity, development of arteriovenous fistula, radial pseudo aneurysm, any access-site complication requiring vascular surgery intervention and costs between the two devices. DISCUSSION The results of this trial should provide valuable additional information on the best approach for haemostasis after transradial percutaneous cardiovascular interventions.
Document Type: article
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Language: English
ISSN: 1983-1447
DOI: 10.1590/1983-1447.2018.2017-0257
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  Data: <i>Revista Gaúcha de Enfermagem</i>. January 2018 39
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  Data: Universidade Federal do Rio Grande do Sul. Escola de Enfermagem, 2018.
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  Data: OBJECTIVE Randomized clinical trial protocol to evaluate the incidence of radial artery occlusion with two different arterial compression devices after transradial procedures. METHODS Barbeau’s test will be performed in adults scheduled to undergo transradial interventional procedures. Those with A, B, or C plethysmographic patterns will be selected. At the end of the procedure, patients will be randomly assigned (1:1) to receive patent haemostasis with TR Band™ device or conventional haemostasis with an elastic adhesive bandage. The primary outcome is the incidence of radial artery occlusion. Secondary outcomes are Barbeau’s test curve change, additional time to achieve haemostasis, incidence of bleeding at the puncture site, pain severity, development of arteriovenous fistula, radial pseudo aneurysm, any access-site complication requiring vascular surgery intervention and costs between the two devices. DISCUSSION The results of this trial should provide valuable additional information on the best approach for haemostasis after transradial percutaneous cardiovascular interventions.
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