DRKS00028119已完成未知
Prospective, multicenter randomized controlled trial of the self-assembling hemostatic gel PuraStat to prevent delayed bleeding after endoscopicresections - PURPLE
Asklepios Kliniken Hamburg GmbH Vertreten durch ASKLEPIOS proresearch Lohmühlenstraße 5 Haus J-D200990 个研究点目标入组 248 人开始时间: 2022年3月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 248
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 study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Age = 18 years
- •- Large (= 10mm in the duodenum or = 20mm in the colorectum) non-peduncled polyps deemed endoscopically resectable. Patients with more than one lesion can be included as long as the cumulative diameter of all resected lesions is no more than 100mm in the colorectum or 50mm in the duodenum. All lesions in the intervention group larger than 5mm must also be treated with PuraStat.
- •- Planned hot snare resection of the polyps (en bloc or piecemeal)
- •- Able and willing to give informed consent
排除标准
- •- Planed Cold snare resection of the polyp
- •- Significantly impaired coagulation (Quick < 50 %, PTT > 50 sec., Platelet count < 50 /nl)
- •- Dual antiplatelet therapy
- •- Single antiplatelet therapy combined with plasmatic anticoagulant agents (Heparin, Direct oral Anticoagulants, Vitamin K Antagonists, etc.)
- •- Pregnancy
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