Last updated on April 2018

Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anaemia Due to Angiodysplasias


Brief description of study

The purpose of this study is to determine whether long-acting octreotide is effective in the treatment of patients with refractory anaemia due to angiodysplasias.

The hypothesis is that long-acting octreotide is effective in decreasing the blood and iron infusion requirements in those patients.

Detailed Study Description

Rationale

Gastrointestinal angiodysplasias are an important cause of difficult to manage bleeding, especially in older patients. Angiodysplasias are technical challenging to manage endoscopic. Some patients are blood transfusion or iron infusion dependent due to rebleedings despite endoscopic intervention. In clinical practice we face difficulties in these patients as there is no known effective alternative treatment. In small cohort studies octreotide appears to decrease the bleeding episodes in those patients, but the evidence is still to weak to integrate this treatment modality in daily practice.

Objective

To assess the efficacy of octreotide in decreasing the need for blood transfusions or iron infusion in patients with refractory anaemia due to gastrointestinal bleedings of angiodysplasias despite endoscopic intervention.

Study design:

Multicenter, randomized, open-label intervention study.

Study population:

62 patients, older than 45 years, with refractory anaemia due to bleeding of angiodysplasias without any other possible source of bleeding, who are blood transfusion or iron infusion dependent despite endoscopic intervention and oral iron supplementation.

Intervention

Patients will be randomized (1:1) into two groups. The intervention group receives Octreotide 40 mg (Sandostatin LAR) once every four weeks for 48 weeks. The control group receives standard of care. The last follow-up visit is in week 60.

Main study parameters/endpoints:

The primary outcome is the percentual decrease in blood and iron requirements between the year prior to inclusion and the treatment period of one year. The percentual decrease will be compared between the intervention and control arm.

Important secondary outcomes are the percent change in the number of rebleeds from baseline to endpoint and the percentage of adverse events. An intention-to-treat analysis will be performed of the outcomes.

Clinical Study Identifier: NCT02384122

Contact Investigators or Research Sites near you

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Gelre Hospitals

Apeldoorn, Netherlands
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Radboudumc

Nijmegen, Netherlands
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Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands
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Catharina hospital

Eindhoven, Netherlands
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VU Medical Center

Amsterdam, Netherlands
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St Antonius Hospital

Nieuwegein, Netherlands
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Bernhoven

Uden, Netherlands
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Recruitment Status: Open


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