PURPOSE: To evaluate the feasibility of shortening the bed rest time from 4 hours to 2 hours after transfemoral noncardiac angiography with a 4-F sheath (outer diameter, 1.93 mm), a 5-F sheath (outer diameter, 2.27 mm), and a 4-F catheter. MATERIALS AND METHODS: Patients were randomized into two groups, receiving either 2 or 4 hours of bed rest after hemostasis by manual compression of the puncture site. The authors evaluated the frequency of bleeding complications. An interim analysis was performed wherein 40 patients were assigned to each group. After the analysis, a single-arm 2-hour bed rest trial was conducted in an additional 115 procedures. RESULTS: In the interim analysis, three of the 40 patients in the 4-hour group and none of the 40 patients in the 2-hour group developed minor bleeding within 2 hours after manual compression (P = .24). After 2 hours of bed rest, no bleeding complication was observed in either group. In the single-arm 2-hour bed rest trial, minor bleeding developed in one of the 115 procedures (0.8%). Through the study, minor bleeding occurred in four of the 195 total procedures (2%), and no major complications developed. The occurrence of a bleeding complication was significantly higher in patients with platelet counts of less than 100 x 10(9)/L than in the other patients (4/67 vs 0/128, P = .01). CONCLUSIONS: Two hours of bed rest is feasible for patients undergoing transfemoral noncardiac angiography by using a 4-5-F sheath and/or a 4-F catheter, especially those with a normal platelet count.
RCT Entities:
PURPOSE: To evaluate the feasibility of shortening the bed rest time from 4 hours to 2 hours after transfemoral noncardiac angiography with a 4-F sheath (outer diameter, 1.93 mm), a 5-F sheath (outer diameter, 2.27 mm), and a 4-F catheter. MATERIALS AND METHODS:Patients were randomized into two groups, receiving either 2 or 4 hours of bed rest after hemostasis by manual compression of the puncture site. The authors evaluated the frequency of bleeding complications. An interim analysis was performed wherein 40 patients were assigned to each group. After the analysis, a single-arm 2-hour bed rest trial was conducted in an additional 115 procedures. RESULTS: In the interim analysis, three of the 40 patients in the 4-hour group and none of the 40 patients in the 2-hour group developed minor bleeding within 2 hours after manual compression (P = .24). After 2 hours of bed rest, no bleeding complication was observed in either group. In the single-arm 2-hour bed rest trial, minor bleeding developed in one of the 115 procedures (0.8%). Through the study, minor bleeding occurred in four of the 195 total procedures (2%), and no major complications developed. The occurrence of a bleeding complication was significantly higher in patients with platelet counts of less than 100 x 10(9)/L than in the other patients (4/67 vs 0/128, P = .01). CONCLUSIONS: Two hours of bed rest is feasible for patients undergoing transfemoral noncardiac angiography by using a 4-5-F sheath and/or a 4-F catheter, especially those with a normal platelet count.
Authors: Scott L Zuckerman; Ritwik Bhatia; Crystiana Tsujiara; Christopher B Baker; Alex Szafran; Deborah Cushing; Judy Aiken; Marilyn Tracy; J Mocco; Robert D Ecker Journal: Interv Neuroradiol Date: 2015-02 Impact factor: 1.610