NL-OMON44271
Completed
Phase 3
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 sites62 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- angiodysplasia
- Sponsor
- Maag-, darm- en leverziekten
- Enrollment
- 62
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •\-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
Outcomes
Primary Outcomes
Not specified
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