NCT02364791进行中（未招募）2 期
A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures on High Risk Population for Prolonged Air Leak (> 5 Days - PAL).
National Cancer Institute, Naples1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- number of days from time of extubation to time of drainage tube removal
研究概览
简要总结
The purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Age ≥18 years
- •High risk of prolonged air leak due to at least one of the following reasons:
- •Preoperative FEV1<80%
- •DLco < 80%
- •LVRS (lung volume reduction surgery o pneumoplastica riduttiva)
- •Anticipation of intraoperative adhesions (ie, redo surgery)
- •Previous induction chemotherapy for locally advanced NSCLC
- •Chronic steroid use
- •Pleural mesothelioma
- •Candidate to one of the following major thoracic surgical intervention:
- •Decortication
- •Reintervention on the same side of the previous intervention
- •Segmentectomy
- •Lobectomy with incomplete fissures on CT scan
- •Written informed consent.
排除标准
- •Pregnancy or breast-feeding
- •Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
- •Any unstable systemic disease (including active infections, any significant hepatic, renal or cardiovascular disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates or prevents or the execution of surgery
- •Known hypersensitivity to bovine proteins or brilliant blue (FD&C Blue No.1)
结局指标
主要结局
number of days from time of extubation to time of drainage tube removal
时间窗: up to 7 days
次要结局
- change in quality of life(baseline, one week, one month)
- number of days to end of air leak(up to 7 days)
- worst grade toxicity per patient(up to 6 weeks)
- number of days from surgical intervention to patient discharge(up to 2 weeks)
研究者
研究点 (1)
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