Shigeki Morita1, Takehisa Matsuda2, Tadashi Tashiro3, Tatsuhiko Komiya4, Hitoshi Ogino5, Nobuhiko Mukohara6, Ryuji Tominaga7. 1. Department of Thoracic and Cardiovascular Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, 1-8-1 Jigyohama, Fukuoka, 810-8563, Japan. morita.shigeki.mu@mail.hosp.go.jp. 2. Division of Biomedical Engineering, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan. 3. Department of Cardiovascular Surgery, University of Fukuoka Medical School, Fukuoka, Japan. 4. Department of Cardiovascular Surgery, Kurashiki Central Hospital, Kurashiki, Okayama, Japan. 5. Department of Cardiovascular Surgery, National Cardiovascular and Research Center, Suita, Osaka, Japan. 6. Department of Cardiovascular Surgery, Hyogo Brain and Heart Center, Himeji, Japan. 7. Division of Cardiovascular Surgery, Graduate School of Medical Science, Kyushu University, Fukuoka, Japan.
Abstract
OBJECTIVES: This study aimed to demonstrate the efficacy and safety of a newly developed elastomeric sealant, which does not require any blood coagulation system to exert its effect, during thoracic aortic surgery. METHODS: This is a multicenter, randomized study conducted in six hospitals in Japan. A total of 81 patients undergoing replacement surgery of a thoracic aortic aneurysm using cardiopulmonary bypass were randomized with a ratio of 2-:1 for those patients designated to receive the sealant (Group S, 54 patients) or those without the usage of the sealant (Group C, 27 patients). The primary endpoints were bleeding from each anastomosis at two time points: (1) immediately before applying protamine and (2) 15 min after applying protamine. The patients were followed for 6 months. RESULTS: The number of anastomoses checked for bleeding was 196 in Group S and 117 in Group C. Before protamine sulfate administration, complete hemostasis was obtained in 155 anastomoses (79%) in Group S compared to 45 anastomoses (38%) in Group C (p < 0.001). Fifteen minutes after the administration of protamine sulfate infusion, bleeding stopped completely in 173 anastomoses (88%) in Group S and in 71 anastomoses (61%, p < 0.001) in Group C. Between the two groups, there were no marked differences in the patient background or in the incidence of major adverse events. CONCLUSIONS: The sealant is effective in achieving hemostasis, even under fully heparinized conditions. The novel sealant is safe and effective in thoracic aortic surgery, one of the most demanding surgical situations for hemostasis.
RCT Entities:
OBJECTIVES: This study aimed to demonstrate the efficacy and safety of a newly developed elastomeric sealant, which does not require any blood coagulation system to exert its effect, during thoracic aortic surgery. METHODS: This is a multicenter, randomized study conducted in six hospitals in Japan. A total of 81 patients undergoing replacement surgery of a thoracic aortic aneurysm using cardiopulmonary bypass were randomized with a ratio of 2-:1 for those patients designated to receive the sealant (Group S, 54 patients) or those without the usage of the sealant (Group C, 27 patients). The primary endpoints were bleeding from each anastomosis at two time points: (1) immediately before applying protamine and (2) 15 min after applying protamine. The patients were followed for 6 months. RESULTS: The number of anastomoses checked for bleeding was 196 in Group S and 117 in Group C. Before protamine sulfate administration, complete hemostasis was obtained in 155 anastomoses (79%) in Group S compared to 45 anastomoses (38%) in Group C (p < 0.001). Fifteen minutes after the administration of protamine sulfate infusion, bleeding stopped completely in 173 anastomoses (88%) in Group S and in 71 anastomoses (61%, p < 0.001) in Group C. Between the two groups, there were no marked differences in the patient background or in the incidence of major adverse events. CONCLUSIONS: The sealant is effective in achieving hemostasis, even under fully heparinized conditions. The novel sealant is safe and effective in thoracic aortic surgery, one of the most demanding surgical situations for hemostasis.
Authors: Domenico Paparella; Crescenzia Rotunno; Pietro Guida; Pietro Giorgio Malvindi; Giuseppe Scrascia; Micaela De Palo; Emanuela de Cillis; Alessandro S Bortone; Luigi de Luca Tupputi Schinosa Journal: Ann Thorac Surg Date: 2011-03-10 Impact factor: 4.330
Authors: Joseph S Coselli; Joseph E Bavaria; John Fehrenbacher; Cary L Stowe; Steven K Macheers; Steven R Gundry Journal: J Am Coll Surg Date: 2003-08 Impact factor: 6.113