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临床试验/EUCTR2008-006887-12-ES
EUCTR2008-006887-12-ES进行中(未招募)1 期

Randomized controlled trial to compare treatment with oral anticoagulation with vitamin K antagonists versus low molecular weight heparin (bemiparin) in patients with anticoagulation criteria and have an episode of gastrointestinal bleeding. - HEPACO

Institut de Recerca HSCSP0 个研究点开始时间: 2011年9月15日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Patients with anticoagulant therapy criteria (acenocoumarol or warfarin-treated) and high or very high risk embolism, which have had an acute gastrointestinal bleeding (low or high) not amenable to endoscopic treatment, vascular lesions secondary to multiple diverticular origin, or with not clear origen (after gastroscopy and colonoscopy) that have no exclusion criteria.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 10
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • A) under 18 years.
  • B) pregnancy.
  • C) patient refusal to participate in the study.
  • D) patients who took the decision not to provide active treatment for the existence of any clinical condition considered terminal (severe associated diseases evolved).
  • E) LMWH contraindication (allergy, heparin-induced thrombocytopenia).
  • F) bleeding secondary to esophageal varices and / or gastric ulcers.
  • G) bleeding associated with peptic injury.
  • H) bleeding secondary to tumors or polyps.
  • i) Presence of portal hypertension with or without liver cirrhosis.
  • J) bleeding due to Mallory-Weiss syndrome.
  • K) anticoagulation low risk for injury embolism.

研究者

发起方
Institut de Recerca HSCSP

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