Randomized trial comparing radial hemostasis techniques; catechol conjugated chitosan pad (InnoSEAL) versus pneumatic compression band.

ABSTRACT

OBJECTIVES: Primary objectives: to compare radial artery occlusion rate (RAO) after cardiac catheterization between catecholamine-chitosan pad (InnoSEAL) and pneumatic compression device (PCD) and to compare difference in hemostasis time and radial monitoring termination time between two arms. Secondary objectives: to compare radial site bleeding and ease of use of two methods by cath-lab technicians. BACKGROUND: Hemostatic pads may be an effective alternative to PCD with lesser chance of access site complications with advantage of shortened compression time. METHODS: Patients (N = 606) undergoing trans-radial, diagnostic or interventional procedures were randomized to either InnoSEAL arm or PCD. RAO was assessed using US Duplex; performed 6-24 hr posthemostatic device removal. Time to hemostasis was recorded as per defined protocols. Ease of use among cath-lab technicians was assessed through 5 point Likert scale. RESULTS: Data of 597 patients was analyzed (299 InnoSEAL, 298 PCD). RAO rate was 8.5% in InnoSEAL and 9.4% in PCD arm (p value >.05). The pooled median hemostasis time and time to termination of radial monitoring was 42 versus 225 min and 50 versus 240 min in InnoSEAL and PCD arms, respectively (p value <.01). There was no difference in Grade I/II hematoma (InnoSEAL 1.3% vs. PCD 3.4%). InnoSEAL was marginally acceptable compared to PCD by technicians. CONCLUSION: Hemostasis time is significantly shorter in InnoSEAL arm with reasonable acceptability to its usage among cath lab staff. RAO and bleeding complications are comparable between the arms. Based on our findings, it seems feasible to include Chitosan based hemostasis pad routinely in cath lab.