Department of Cardiovascular Sciences, Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.
Int J Cardiol. 2012 Apr 5;156(1):53-4. doi: 10.1016/j.ijcard.2010.10.030. Epub 2010 Nov 18.
Bleeding and vascular access site complications are an important cause of morbidity after percutaneous femoral procedures. Together with collagen-based and suture-based vascular closure devices, new hemostatic dressings have been developed to control heavy bleeding.
To evaluate safety and efficacy results of the first clinical QuikClot Interventional Hemostatic Bandage use for femoral artery closure after diagnostic or interventional procedures.
The first European safety study was performed at the Centro Cardiologico Monzino in Milan, Italy, on January 2010. Forty consecutive patients (75% male, mean age 68 ± 11years) undergoing diagnostic angiography (62%) or PCI (38%) by femoral approach with a 6- (90%) or 7-Fr (10%) size introducer, received arterial sheath removal with the QuikClot Interventional gauze use. The mean ACT value at hemostasis time was 138 ± 24s (range 95-186s). Hemostasis was achieved in a mean time of 4.9 ± 0.5 min. Only one hemostasis failure occurred requiring prolonged mechanical compression. Neither major bleeding, re-bleeding nor hematoma occurred after early (4h after procedure) ambulation.
QuikClot Interventional Bandage obtained prompt hemostasis and allowed for an early ambulation without clinical complications.
出血和血管入路部位并发症是经皮股动脉操作后发病率增高的一个重要原因。除了基于胶原和缝合的血管闭合装置,新型止血敷料也被开发出来用于控制大出血。
评估第一代 QuikClot 介入止血绷带在诊断或介入手术后用于股动脉闭合的安全性和有效性结果。
这项研究于 2010 年 1 月在意大利米兰的 Centro Cardiologico Monzino 进行,为第一项欧洲安全性研究。40 例连续患者(75%为男性,平均年龄 68 ± 11 岁)接受经股动脉入路的诊断性血管造影(62%)或经皮冠状动脉介入治疗(38%),使用 6-Fr(90%)或 7-Fr(10%)大小的动脉鞘管,使用 QuikClot 介入止血纱布进行动脉鞘管拔出。止血时的平均 ACT 值为 138 ± 24s(范围 95-186s)。平均止血时间为 4.9 ± 0.5min。仅 1 例发生止血失败,需要长时间机械压迫。早期(术后 4 小时)下床活动后无大出血、再出血或血肿发生。
QuikClot 介入止血绷带可迅速止血,并允许早期下床活动而无临床并发症。