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USF Hemostasis: USage of HemCon for Femoral Hemostasis After Percutaneous Procedures

Meir Medical Center · 2008
ClinicalTrials.gov · Datasets · License: Public Domain · 2008
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USF Hemostasis - USage of HemCon for Femoral Hemostasis after Percutaneous Procedures. A Comparative Open Label Study The purpose of this trial is to test HemCon pad after diagnostic percutaneous coronary angiography as an adjunct to manual compression to better control vascular access site bleeding and reduce time-to-hemostasis. We hypothesize that the use of HemCon bandage (containing a carbohydrate called chitosan, found in the shells of shrimp, lobster and beetles) will shorten the time needed to achieve hemostasis, time to patient's ambulation, and patient's satisfaction without increasing vascular complications. 278 patients undergoing diagnostic coronary angiography receiving 2500 u intravenous Heparin will be studied and randomized for manual homeostasis with either a HemCon or a regular pad. Primary efficacy endpoint will be time to hemostasis. Secondary endpoints will be safety (complication rate) and satisfaction of patients regarding time to sitting incline and time to ambulation. 25% of patients from each arm will be randomized for Duplex examination of the femoral artery at the access site.
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