Single Center, Single Arm, Open-label, Exploratory Clinical Trial to Evaluate the Safety and Efficacy of HLBLS-200 in Patients Requiring Hemostatic Technique for Oozing Hemorrhage During Liver Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Adverse Event
研究概览
简要总结
This is a prospective, open-label, exploratory clinical trial designed to investigate the safety and efficacy of HLBLS-200 (an investigational hemostatic agent). The study will recruit approximately 8 subjects.
详细描述
Patients scheduled for hepatic resection who voluntarily agree to participate the study will be recruited for the screening procedures.
Patients who meet the eligibility criteria will be assigned to the study. Subjects will receive HLBLS-200 as a supplementary hemostatic technique for oozing hemorrhage which can be occurred during hepatic resection.
A dose of HLBLS-200 based on the area of liver resection will be applied and time to hemostasis of blood oozing will be evaluated.
Patients will be followed for 12 weeks after application of HLBLS-200 to monitor any adverse event.
Study objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(during screening period)
- •Subject aged between 18 and 80 years old and scheduled for non-emergent hepatic resection.
- •Subject is willing to provide written consent and able to comply with study procedures.
- •Female subject of childbearing potential who is willing to use an adequate method of contraception or to be abstinent during the course of the study.
- •Inclusion Criteria: (during hepatectomy)
- •Subjects who need to receive additional hemostatic treatment for blood oozing at the resection site after application of primary hemostatic methods.
排除标准
- •(during screening period)
- •Subject with a history of bleeding disorder, platelet disorder or bone marrow disorder.
- •Platelet count < 50 X 10^9/L or International normalized ratio >
- •Subject who received any drug affecting hemorrhage and/or hemostasis such as anticoagulants, antiplatelet agents or thrombolytic agent within 2 weeks prior to hepatectomy.
- •Subject with a history of hypersensitivity to the substance of the investigational device.
- •Creatinine clearance < 30mL/min
- •Aspartate transaminase or alanine aminotransferase ≥ 3.0 X upper limit of normal.
- •Subject with a suspected disorder of decrease in fibrinolytic activity such as disseminated intravascular coagulation.
- •Subject with a history of alcohol or drug abuse.
- •Pregnant or lactating women
- •Subject who have participated in other clinical trial and have received investigation drugs or devices within 4 weeks prior to participation in the study.
- •Subject who were judged by the investigator as inadequate for participation in the study.
- •Exclusion Criteria: (during hepatectomy)
- •Subject with following major bleeding (e.g. spurting hemorrhage, hemorrhage from hepatic veins) despite application of primary hemostatic methods
- •Subject who is deemed to need anticoagulant treatment within 48 hours of hepatectomy.
- •For other reason, subject who were judged by the investigator as inadequate for participation in the study.
结局指标
主要结局
Adverse Event
时间窗: up to 12 weeks
Incidence of Adverse Event after application of HLBLS-200
Hemostasis at the target blood oozing site
时间窗: within 3 minutes
Proportion of participants achieving hemostasis within 3 minutes after HLBLS-200 application
次要结局
- Time to hemostasis(within 10 minutes)
- Proportion of participants with abnormal laboratory value(up to 12 weeks)
- Hemostasis at the target blood oozing site(within 10 minutes)
- Proportion of participants with operation site bleeding after hepatectomy(up to 12 weeks)