Ankaferd blood stopper as a new strategy to avoid early complications after transradial procedures: A randomized clinical trial

Background We planned a three arm randomized study to evaluate the safety and efficacy of a new blood stopper, Ankaferd blood stopper (ABS) along with short‐time compression, compared to either short‐time compression with conventional sterile gauzes (CSG) or with a TR band after transradial (TRA) procedures. Methods The Ankaferd blood stopper as a new strategy to avoid early complications. After transradial procedures (ABS transradial) trial is designed in a prospective, randomized, placebo‐controlled fashion and registered with http://clinicaltrials.gov (NCT02982733). Six hundred and thirty patients were randomized into three arms in a 1:1:1 fashion corresponding to three different strategies of patent hemostasis techniques after diagnostic or interventional catheterization. Results One (0.49%) patient in the CSG group and one patient (0.48%) in the TR Band group developed RAO at the end of the hemostasis, compared with 0 (0%) in the ABS group. At 30 days follow‐up none of the groups had any patients with RAO. As a secondary end‐points the difference was not statistically significant regarding hematoma among the three groups ( P = 0.70). Bleeding during deflation of the TR Band or removal of the elastic bandage occurred in 55 patients (26.96%) in the CSG group and in 56 (27.31%) patients in the TR Band group compared to 19 patients (9.40%) in the ABS group ( P < 0.001). Conclusion Ankaferd blood stopper is a promising device for use in patent hemostasis, with no evidence on RAO at short‐term or long term and with reduced risk of re‐bleeding at the end of hemostasis.