A validation study of hemostatic effect of SC-625A at anastomotic sites -Multicenter open-label randomized clinical study- - Hemostatic effect of the novel synthetic sealant (SC-625A) at anastomotic sites
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
研究概览
简要总结
Efficacy Primary endpoints: The hemostatic rate immediately before protamine sulfate administration was 79.1% in the SC-625A group and 38.5% in the control group. The hemostatic rate 15 minutes after protamine sulfate administration was 88.3% in the SC-625A group and 60.7% in the control group. The SC-625A group showed a significant difference in the hemostatic rate at each point compared to the control group (p < 0.001, Fisher's exact test). Secondary endpoints: There was a significant difference in the percentage of additional hemostatic procedures performed after protamine sulfate administration between the 2 groups: 19.4% anastomoses in the SC-625A group and 55.6% anastomoses in the control group (p < 0.001, Fisher's exact test) required an additional hemostatic procedure. There was a slight, but not significant, difference (p = 0.057) in the transfusion volume of frozen plasma between subjects in the control and SC-625A groups. Safety There was no additional risk attributable to the use of SC-625A in subjects who underwent thoracic aorta replacement surgery compared to subjects who underwent thoracic aorta replacement without the use of SC-625A.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Ruptured aneurysm 2)Acute dissection 3)Reoperation (reoperation performed using the same incision site) 4)Patients with a serious infection that may affect evaluation for the study, in the opinion of the study investigator or sub-investigator 5)Patients with severe anemia who were judged ineligible for the study by the study investigator or sub-investigator (hemoglobin level: <9.0 g/dL) 6)Patients with serious complications involving the liver, kidney, or lung The seriousness was judged based on the following criteria: Total bilirubin level, >3.0 mg/dL;creatinine, >2.0 mg/dL;forced expiratory volume in 1 second, <1.0 L, PaO2 (room air), <60 mmHg,or SpO2 (room air), <90% 7)Patients with existing coagulation or fibrinolytic system abnormalities before the surgery, for whom continuous treatment of the condition was necessary postoperatively (FDP, >30 ug/mL [or FDP-E, >210 ng/mL], or platelet count, <100,000/mm3) 7)Patients with existing coagulation or fibrinolytic system abnormalities before the surgery, for whom continuous treatment of the condition was necessary postoperatively (FDP, >30 ug/mL [or FDP-E, >210 ng/mL], or platelet count, <100,000/mm3) 8)Patients taking oral corticosteroids 9)Patients with diabetes mellitus whose glucose control was judged to be inadequate (Hb A1c> 8.0%) 10)Patients with a cerebrovascular or neurological disorder who were judged ineligible for the study by the study investigator or sub-investigator 11)Pregnant women 12)Patients undergoing aortic root replacement (Bentall operation, valve-sparing aortic root replacement) 13)Patients participating in other clinical trials 14)Other patients who were judged ineligible by the study investigator or sub-investigator