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001-es BibID:	BIBFORM121142
035-os BibID:	(Scopus)85138602528 (WoS)000808537600001
Első szerző:	Kulyassa Péter
Cím:	The Design and Feasibility of the : Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial / Péter Kulyassa, Balázs T. Németh, Réka Ehrenberger, Zoltán Ruzsa, Tibor Szük, Péter Fehérvári, Marie Anne Engh, Dávid Becker, Béla Merkely, István F. Édes
Dátum:	2022
ISSN:	2297-055X
Megjegyzések:	Introduction and Aim: Radial artery approach angiography is the current gold standard for coronary status diagnostics and eventual percutaneous revascularization (PCI). Currently, application of adequate, patent hemostasis based physical torniquets are used for puncture site control, to avoid bleeding, radial artery occlusion and damage (RAO and RAD). The Radial Artery Puncture Hemostasis Evaluation (RAPHE) is a prospective, randomized, multicenter clinical trial designed to investigate new, simplified techniques of radial artery hemostasis utilizing physical compression free methods. Methods and Results: The RAPHE study has been designed to evaluate the efficacy and safety of two non-compression based radial artery hemostasis methods: a 100% chitosan bioactive hemostatic dressing and a purpose-built radial potassium-ferrate based topical hemostasis disc. These devices will be investigated in a standalone configuration. Control group is a standard pneumatic airbladder-based compression device. A total of 600 patients will be enrolled in a three-way randomization (1:1:1) with two study and one control groups. Safety and efficacy endpoints are RAO, puncture site hematoma formation and RAD respectively, consisting of dissection, (pseudo)aneurism and/or fistula formation, measured post-procedure and at sixty days. Conclusion: The results from this trial will provide valuable information on new, simplified methods of radial artery hemostasis options and possibly simplify post-puncture management of patients.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk bleeding hemostasis radial artery occlusion radial artery damage radial approach angiography
Megjelenés:	Frontiers in Cardiovascular Medicine. - 9 (2022), p. 1-7. -
További szerzők:	Németh Balázs Tamás Ehrenberger Réka Ruzsa Zoltán Szűk Tibor (1967-) (kardiológus) Fehérvári Péter Engh, Marie Anne Becker Dávid Merkely Béla (1965-) (orvos) Édes István Ferenc (1980-) (kardiológus)
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