跳至主要内容
临床试验/NCT05443815
NCT05443815Unknown不适用

Prospective Multicenter Registry on the Use of HaemoCer-PLUSPlus in the Treatment and Prevention of Post-resectional Bleeding

Istituto Clinico Humanitas Mater Domini1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Number and proportion of bleeding events in patients receiving HaemoCer-PLUS

研究概览

简要总结

Gastrointestinal bleeding is defined as clinical evidence of bleeding manifested by melena, hematochezia that required endoscopic hemostasis. GI bleeding associated to endoscopic procedure is defined as clinical evidence of bleeding and a drop in hemoglobin of ≥ 2g/dL on the day of the procedure (early bleeding) or up to 14 days after the procedure (delayed bleeding).GI bleeding is, nevertheless, a common complication of endoscopic procedures, such as endoscopic mucosal resection (EMR) and endoscopic sub mucosal dissection (ESD). For example, colorectal ESD, which is technically more difficult than gastric or esophageal ESD because of the anatomical features of the colon, present an increased risk of delayed bleeding. According to literature, early bleeding occurs on average in 5,3% of endoscopic resections of the whole digestive tract, with bleeding rates per location as follows: esophagus 9.4%, stomach 9.1%, duodenum 3.6%, colon 3.4%. Concerning delayed bleeding, it is assessed to complicate 3.1% of endoscopic resection procedures. The bleeding rate in the duodenum is usually the highest (6.3%), followed by colon at (3.6%), stomach (1.5%) and esophagus (0.9%). Age, lesion size and piecemeal resection are associated with an increased risk of bleeding. Usage of aspirin or NSAIDs seems to not increase risk of post-polypectomy bleeding, while clopidogrel and warfarin do and should be discontinued in the periprocedural period to prevent the occurrence of post-polypectomy bleeding. Direct oral anticoagulants (DOAC) administration shows similar post-procedural gastrointestinal bleeding risk to anti-vitamin K antagonists (VKA) administration in patients undergoing endoscopic procedures.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who had authorized to use and process their personal details for the purpose of research;
  • patients able to express their consent;
  • age >18 years;
  • endoscopic procedures where HaemoCer-PLUS has been used for hemostasis or prevention of bleeding

排除标准

  • hemostatic therapies other than HaemoCer-PLUS
  • Known coagulopathy likely to affect risk of bleeding.

结局指标

主要结局

Number and proportion of bleeding events in patients receiving HaemoCer-PLUS

时间窗: 6 months

Number and proportion of bleeding events controlled by application of HaemoCer

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas Mater Domini
申办方类型
Other
责任方
Sponsor

研究点 (1)

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