A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness and Safety of CELSTAT as an Adjunct to Hemostasis for Tissue Bleeding in Cardiothoracic, General, and Vascular Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 44
- 主要终点
- Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration
研究概览
简要总结
The study is to evaluate the effectiveness and safety of CELSTAT vs active control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative
- •Subject is undergoing planned cardiothoracic, general or vascular surgery
- •Intraoperative
- •Mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical.
排除标准
- •Preoperative
- •Subject needs emergency surgery
- •Subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery
- •Subject will undergo neurological or ophthalmological surgery
- •Subject will undergo urological or gynecological surgery
- •Subject has congenital coagulation disorder
- •Subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery
- •Intraoperative:
- •Occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site
- •Disseminated intravascular coagulopathy
结局指标
主要结局
Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration
时间窗: Day 1 to Day 91
Findings are reported in this outcome measure and would have also been reported as an AE.
Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application
时间窗: 5 minute (post-application)
Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.
次要结局
- Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application(10 minutes (post application))
- Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application(7 minutes (post application))
- Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis(0 to 10 minutes (post-application))
- Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious)(Day 1 to Day 91)
- Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application(3 minutes (post application))
- Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants(0 to 10 minutes (post-application))