jRCT2031230363进行中（未招募）不适用
A Single-blind, Randomized, Controlled, Parallel-group, Comparative Study Evaluating the Safety and Effectiveness of VER-01 as an Adjunct to Hemostasis During Cardiovascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
- 主要终点
- success rate of hemostasis
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Single Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Pre-operative
- •1.Subject undergoing elective, open, revascularization surgery such as bypass grafting and replacement of vascular prostheses for coronary artery, aorta (including thoracic and abdominal) and peripheral artery and arteriovenous shunt procedure.
- •2.At least 18 years of age at the time of informed consent.
- •3.Willingness to comply with the protocol.
- •4.Willingness to give consent before all study-related activities.
- •Intra-operative
- •1.Target bleeding site (mild and moderate bleeding) is identified, and requires adjunctive hemostasis determined by principal investigators and sub-investigators.
排除标准
- •Pre-operative
- •1.Subjects with serious hepatic impairment (Either AST(GOT) or ALT(GPT) > 5 times the upper limit of site reference value).
- •2.Subjects suspected of having disseminated intravascular coagulation (DIC) (e.g., sepsis, acute leukemia, solid tumors).
- •3.Subjects who have intolerance to any of the components of the investigational or comparator products (including bovine-derived ingredients).
- •4.Subjects who are not willing to use blood products.
- •5.Subjects with immunodeficiency or undergoing treatment for immunodepression.
- •6.Subjects with hemolyzing property or blood loss anemia.
- •7.Subjects of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period.
- •8.Subjects who are breastfeeding.
- •9.Subjects who have participated in or will participate in another clinical trial of another a test drug/device within 30 days before and after a surgery of the clinical trial.
- •10.Subjects judged to be inappropriate by the principal investigator or sub-investigator.
- •Intra-operative
- •1.Subjects bleeding from only parenchyma tissue.
- •2.Subjects with an actively infected field of potential target bleeding site
- •3.Subjects who have serious complication in surgeries requiring emergency resuscitation or changing of planned surgeries.
- •4.Subjects judged to be inappropriate by the principal investigator or sub-investigators.
结局指标
主要结局
success rate of hemostasis
时间窗: 5 minutes following treatment application
hemostasis at 5 minutes following treatment application and with no re-bleeding requiring treatment at the TBS any time prior to initiation of final chest wall closure
次要结局
未报告次要终点
研究者
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