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.
- Conditions
- angiodysplasiavascular malformation10017959
- Registration Number
- NL-OMON44271
- Lead Sponsor
- Maag-, darm- en leverziekten
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
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.
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The percentual decrease in blood and iron requirements between the year prior<br /><br>to inclusion and the treatment period of one year.<br /><br>Percentual decrease = (number of blood transfusions and iron infusions in the<br /><br>year prior to inclusion -<br /><br>number of blood transfusions and iron infusions during the study period ) /<br /><br>number of blood and iron infusions in the year prior to inclusion.<br /><br>The percentual decrease will be compared between the intervention and control<br /><br>arm.<br /><br><br /><br>All blood transfusions that are given with another indication than<br /><br>gastrointestinal blood loss are registered, but excluded for analysis for the<br /><br>primary outcome. </p><br>
- Secondary Outcome Measures
Name Time Method