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.

Complications and Related Risk Factors of Transradial Access Cannulation for Hemodynamic Monitoring in General Surgery： A Prospective Observational Study

“…Therefore, the compression strength could not be standardized and quanti ed. Based on clinical practice and relevant literature [31] , the compression time was set to 40 minutes; however, it remains unclear whether this time was su cient for achieving hemostasis. Taken together, the aforementioned factors could have contributed to the ineffectiveness of traditional manual compression and may explain why bleeding/hematoma was the most common complication in our study.…”

Artificial Scaffolds in Cardiac Tissue Engineering

“…Nevertheless, recent research has been devoted to studying the potential use of chitosan-based biomaterials as an injectable therapy delivering progenitor cells [ 124 ]. Because of its hemostatic properties, chitosan has been used in chitosan-based pads to improve hemostasis following transradial arterial access in a couple of clinical studies [ 125 , 126 ] and a few more ongoing clinical trials (NCT04380883, NCT04857385, NCT03522077, NCT02837744).…”

Applications of Chitosan in Surgical and Post-Surgical Materials

“…The application of the pad on the puncture site proved to be effective in significantly reducing the time required to seal the hemorrhage-it was reduced from 18.5 to 3 min in arterial access and from 13.2 to 2.8 min in a venipuncture site [178]. The InnoSeal hemostatic pad is a commercially available catecholamine-chitosan pad, capable of significantly reducing hemostasis time after cardiac catheterization compared to other available pads [179]. Similarly, the Clo-Sur Plus Radial TM pad is another chitosan-based hemostatic pad evaluated for sealing bleeding after transradial arterial access.…”