NL-OMON44271已完成3 期
A randomised, open-label clinical trial assessing the efficacy of octreotide to decrease iron infusion and blood transfusion requirements in patients with refractory anaemia due to gastrointestinal bleeding from angiodysplasias. - OCEAN-study
Maag-, darm- en leverziekten0 个研究点目标入组 62 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with refractory anaemia due to gastrointestinal bleeding from angiodysplasias without any other possible source of bleeding, who are blood transfusion or iron infusion dependent despite endoscopic intervention and oral iron supplementation.
- •1. Diagnosis of angiodysplasia is made by upper, lower gastrointestinal endoscopy, video capsule or enteroscopy. Single or multiple 2-5 mm flat bright red spots with round uniform or slightly irregular margins, or lesions appearing as raised and reddened areas with a distinctly irregular margin, when larger than 5 mm are seen.
- •2. Transfusion dependent: at least 4 blood transfusions or iron infusions in the year before inclusion, despite an attempt to supplement iron orally.
- •3. Failure of endoscopic therapy: at least one attempt with single balloon enteroscopy or dubbel balloon enteroscopy to coagulate the angiodysplasias with APC within the year of diagnosis of symptomatic AD.
排除标准
- •-age < 45 years
- •-liver cirrhosis Child-Pugh C, liver failure or diagnosed portal hypertension
- •-previous unsuccessful treatment with octreotide for the same indication (refractory anaemia due to angiodysplasias)
- •-current thalidomide treatment which is effective (no blood transfusion dependency)
- •-severe diseases with life expectancy < 1 year
- •-patients with left ventricular assist devices (LVAD*s)
- •-Rendu-Osler-Weber
- •-pregnancy or nursing women
- •-uncontrolled diabetes as defined by HbA1C >64 mmol/ml, despite adequate therapy
- •-hereditary hemorrhagic diseases or haematological disorders with active treatment
- •-patients with a known hypersensitivity to SST analogues or any component of the sandostatin LAR formulations
- •-symptomatic cholecystolithiasis
- •-non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with this study treatment
- •-systemic cancer currently undergoing chemotherapy or radiation therapy
- •-refusal to enter the study
- •-no understanding of Dutch or English
研究者
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