jRCTs042230072进行中（未招募）不适用
Feasibility and safety study of PuraStat (a novel self-assembling peptide) for exudative hemorrhage after stapling of pulmonary artery during thoracic surgery
未提供0 个研究点目标入组 21 人开始时间: 2023年9月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 主要终点
- -
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Age 18 years or older
- •(2) ECOG performance status (PS) is 0 or 1
- •(3) Planned surgery is scheduled within 2 weeks
- •(4) Patient is scheduled for an anatomical lung resection (segmentectomy, lobectomy, bilobectomy, pneumonectomy or a combination of these surgical procedures)
- •(5) Major organ function is preserved
- •(6) Written informed consent has been obtained
排除标准
- •(1) Patients with a history of coagulation disorder
- •(2) Patients with psychiatric disorders that make it difficult to include in the study
- •(3) Patients receiving continuous systemic administration of steroids or immunosuppressants
- •(4) Patients with a history of hypersensitivity to peptide or protein products
- •(5) Patients with a history of serious hypersensitivity
结局指标
主要结局
-
Rate of additional hemostatic treatment required
次要结局
未报告次要终点