[Chitosan pads vs. manual compression to control bleeding sites after transbrachial arterial catheterization in a randomized trial].
PURPOSE: Until now, no mechanical closure devices were available to achieve fast and secure hemostasis for vessel closure after catheterization of small arterial vessels. MATERIAL AND METHODS: Eighty patients were randomized to evaluate the effect on hemostasis by use of a chitosan pad (Chito-Seal, Abbott Vascular Devices, Galway/Ireland) in comparison to manual compression after diagnostic transbrachial arterial catheterization. Hemostasis after three minutes and one hour as well as local development of a hematoma after one and twenty-four hours were assessed. RESULTS: The use of chitosan pads significantly decreased the bleeding time in the first three minutes after manual compression time (p < 0.01). Significant decrease in bleeding risk at three minutes by use of the chitosan closure pads was also found in subgroups of patients with hypertension (p < 0.001) or diabetes (p < 0.01) and also in patients under anticoagulation therapy (p < 0.01). In addition, long-term protection from bleeding complications such as the risk of hematoma was decreased by the use of chitosan closure pads one hour (p < 0.01) or twenty-four hours (p < 0.001) after catheter removal. CONCLUSION: The use of an intravascular anchor or suture system is not safely applicable in these vessels due to the small diameter of the brachial artery. Our results document a significant improvement in hemostasis by using chitosan pads in these cases.