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

What Was Tested

In this phase 3 trial, researchers set out to test Octreotide for anemia.

It had two arms (groups): Octreotide (active comparator) and Standard of care (no intervention).

Patients receive standard of care without a placebo.

The registry classes the interventions as drug.

More on the Plan

Rationale: Gastrointestinal angiodysplasias are a common source of intractable small bowel bleeding, especially in older patients.

Recurrent bleeding results in refractory anemia which is managed with blood transfusions and/or iron infusions.

Study population: Patients aged 18 years or older with transfusion-dependent anemia due to endoscopically confirmed angiodysplasias.

Who Took Part

Enrollment: 62 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Endoscopically diagnosed angiodysplasias. Failure of endoscopic therapy: at least one endoscopic attempt to coagulate the angiodysplasias or unsuitable for endoscopic procedures. Providing informed consent. Older than 18 years.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: liver cirrhosis child-pugh c, liver failure or diagnosed portal hypertension; previous treatment with octreotide for the same indication (refractory anemia due to angiodysplasias); life expectancy \< 1 year.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the anemia participants stayed in one arm throughout.

Only one side, usually the anemia participants, was kept unaware of whether Octreotide was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2015-09 with completion listed for 2022-07.

It ran at 12 sites in Netherlands (12).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Difference in blood and parenteral iron requirements (transfusion units) (time frame: Study year (52 weeks)).

It also tracked 12 secondary outcomes, for example Proportion with a good treatment response, Use of concomitant care, Difference in endoscopic procedures, Difference in bleeding episodes, Difference in healthcare utilization and Difference in hemoglobin levels.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 62 people with anemia.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, Anemia research.