Multicentre, open-label, randomised, parallel-group, superiority study to compare the efficacy of octreotide therapy [amount hidden] monthly versus standard of care in patients with refractory anaemia due to gastrointestinal bleeding from small bowel angiodysplasias: a protocol of the OCEAN trial

What Was Tested

This randomized controlled trial paper looks at Octreotide.

Gastrointestinal angiodysplasias are an important cause of difficult-to-manage bleeding, especially in older patients.

Endoscopic coagulation of angiodysplasias is the mainstay of treatment, but may be difficult for small bowel angiodysplasias because of the inability to reach them for endoscopic intervention.

Who Took Part

The abstract describes 62 patients taking part.

PubMed indexes the participants as middle-aged adults.

62 patients will be included with refractory anaemia due to small bowel angiodysplasias, who are RBC transfusion or iron infusion dependent despite endoscopic intervention and oral iron supplementation.

How the Study Was Run

The researchers set it up as a randomized, open-label and multicenter study.

Random assignment meant chance, not the researchers, decided who got Octreotide and who got the comparison, which limits bias.

Being open-label, the Octreotide study did not mask who received what.

More than one site took part, so the patients came from several places.

The follow-up period is 8 weeks.

What Was Measured

Gastrointestinal angiodysplasias are an important cause of difficult-to-manage bleeding, especially in older patients.

The subject headings attached to it are Anemia, Refractory, Angiodysplasia, Gastrointestinal Agents, Gastrointestinal Hemorrhage, Intestine, Small, Netherlands and Octreotide.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Octreotide in 62 patients.

The abstract goes on to report its results in about 2 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2016 (BMJ open), a journal based in England.

More context: the Octreotide compound page, all human trials.