Kulyassa Péter, Németh Balázs T, Ehrenberger Réka, Ruzsa Zoltán, Szük Tibor, Fehérvári Péter, Engh Marie Anne, Becker Dávid, Merkely Béla, Édes István F
Heart and Vascular Center, Semmelweis University, Budapest, Hungary.
Center for Translational Medicine, Semmelweis University, Budapest, Hungary.
Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022.
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.
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.
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.
[www.ClinicalTrials.gov], identifier [NCT04857385].
桡动脉途径血管造影术是目前用于冠状动脉状况诊断及最终经皮血管重建术（PCI）的金标准。目前，基于物理止血带的合适、有效的止血方法被用于穿刺部位控制，以避免出血、桡动脉闭塞和损伤（RAO和RAD）。桡动脉穿刺止血评估（RAPHE）是一项前瞻性、随机、多中心临床试验，旨在研究利用无物理压迫方法的新型简化桡动脉止血技术。
RAPHE研究旨在评估两种基于非压迫的桡动脉止血方法的有效性和安全性：一种100%壳聚糖生物活性止血敷料和一种特制的基于高铁酸钾的桡动脉局部止血盘。这些装置将以独立配置进行研究。对照组是一种基于标准气动气囊的压迫装置。总共600名患者将被纳入三方随机分组（1:1:1），分为两个研究组和一个对照组。安全性和有效性终点分别是RAO、穿刺部位血肿形成和RAD，包括夹层、（假性）动脉瘤和/或瘘管形成，在术后及60天时进行测量。
该试验结果将为新型简化的桡动脉止血方法提供有价值的信息，并可能简化患者穿刺后的管理。
[www.ClinicalTrials.gov]，标识符 [NCT04857385]。
