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临床试验/NCT04239118
NCT04239118已完成不适用

New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers

Voronezh N.N. Burdenko State Medical Academy2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2018年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
112
试验地点
2
主要终点
the timing of final hemostasis

研究概览

简要总结

The purpose of the study was to improve treatment results of patients with bleeding gastroduodenal ulcers by endoscopic applications of autoplasma, enriched with platelets and granular sorbent aseptisorb-A.

详细描述

The clinical study was conducted on the basis of the Voronezh city specialized Center for the treatment of patients with gastrointestinal bleeding. The study included 112 patients with ulcerative gastroduodenal bleeding. All patients were divided into two groups by random sampling: the main group (n=57 people) and the comparison group (n=55 people). In the treatment of patients of the main group (57 people), an individual approach was used with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets, in the complex endoscopic treatment of bleeding-complicated gastroduodenal ulcers (Patent Russian Federation (RF) № 2632771). In the comparison group (55 people), traditional methods of endoscopic hemostasis were used.

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
44 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gastroduodenal ulcers with bleeding

排除标准

  • Bleedings of other etiology

结局指标

主要结局

the timing of final hemostasis

时间窗: a week

the timing of final hemostasis

次要结局

  • the frequency of recurrent bleeding(1 year)
  • mortality rates(1 year)
  • healing of ulcerative defects(1 year)

研究者

发起方
Voronezh N.N. Burdenko State Medical Academy
申办方类型
Other
责任方
Sponsor

研究点 (2)

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