Hemopatch Performance Evaluation: A Prospective Observational Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 621
- 试验地点
- 15
- 主要终点
- Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery
研究概览
简要总结
To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients of any age
- •Patients who had undergone open or minimal invasive surgical (MIS) procedures requiring the use of a patch to achieve dura repair, hemostasis, or control of leakage of air or other body fluid when pressure, ligature or other conventional procedures had been ineffective or impractical and where use of hemopatch was deemed appropriate by the surgeon according to its IFU in the following organ systems:
- •Hepato-biliary (liver, pancreas, gallbladder)
- •General surgery (in thyroid and other regions)
- •Cardiovascular (heart and vessels)
- •thoracic (lung and mediastinum)
- •Urological (kidney, prostate, and bladder
- •Neurological (dura mater, brain and spinal cord)
- •Provision of written informed consent/assent, as applicable, up to 72 hours after the date of surgery
排除标准
- •Patients with known hypersensitivity to bovine proteins or brilliant blue
- •Patients who had intraoperative pulsatile or severe bleeding at the target application site (TAS)
- •Patients who had an active infection at the TAS
结局指标
主要结局
Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery
时间窗: Up to 4 weeks (postoperative)
Number of patients with related Adverse Events
时间窗: Up to 4 weeks (postoperative)
Number of patients with chest tube drainage >=5 days after thoracic/lung surgery
时间窗: Day 5 up to 4 weeks (postoperative)
Number of patients needing reinsertion of chest tube for pneumothorax after thoracic/lung surgery
时间窗: Up to 4 weeks (postoperative)
Duration of bile leakage after hepatobiliary surgery
时间窗: Up to 4 weeks (postoperative)
Number of patients with postoperative cerebrospinal fluid (CSF) leakage after neurological surgery
时间窗: Up to 4 weeks (postoperative)
External or internal accumulation including pseudomeningocele
Tight closure achieved in dura mater at time of surgical closure
时间窗: Day 1 (intraoperative)
No leak after inspection per local standard of care
Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure
时间窗: Day 1 (intraoperative)
Absence of air leak in lung at time of surgical closure
时间窗: Day 1 (intraoperative)
Number of patients with postoperative urinary fistula formation after urological surgery
时间窗: Up to 4 weeks (postoperative)
Gastrointestinal anastomosis leakage/fistula after general surgery
时间窗: Up to 4 weeks (postoperative)
Percentage of patients achieving hemostasis after 2 minutes of surgery
时间窗: Day 1 (up to 2 minutes postoperative)
次要结局
- Number of Hemopatch units applied(Up to 4 weeks (postoperative))
- Number of intraoperative transfusions by type and amount of blood product transfused(Day 1 (intraoperative))
- Assessment of product tissue adherence(Day 1 (intraoperative))
- Product characteristics liked least by Surgeon(Day 1 (intraoperative))
- Surgery duration(Day 1 (intraoperative))
- Length of hospital stay(Up to 4 weeks (postoperative))
- Ease of product preparation(Day 1 (intraoperative))
- Ease of product handling(Day 1 (intraoperative))
- Surgeon's overall satisfaction of product(Day 1 (intraoperative))
- Product characteristics appreciated by Surgeon(Day 1 (intraoperative))
- Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage(Up to 4 weeks (postoperative))
- Number of postoperative transfusions by type and amount of blood product transfused up to 72 hours after surgery(Up to 72 hours (postoperative))