Clinical trial NCT03367897: Bleeding Ulcer and Erosions Study "BLUE Study"
Official title: Bleeding Ulcer and Erosions Study "BLUE Study"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Peptic Ulcer
Bleeding Ulcer
Keywords: Helicobacter pylori
peptic ulcer
erosions
bleeding
Nsaids
Noac
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
Collaborators: name: University Hospital, Akershus
First posted: 2017-12-11
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hematemesis and/or melena, anemia or positiv FOBT that during gastroscopy are diagnosed with ulcer and/or erosions of the ventricle and/or duodenum. Gastroscopy must be performed within 24 hours of the findings above.

Brief summary: A prospective study of bleeding peptic ulcers and/or erosions in the upper gastrointestinal tract - risk-medication, presence of Helicobacter pylori, treatment and outcome.

Detailed description: Patients admitted to hospital due to hematemesis and/or melena with endoscopic finding of ulcer and/or erosion in the ventricle and/or duodenum are eligible for inclusion in the BLUE study after an informed consent has been obtained. The gastroscopy must be performed within 72 hours after admission. Epidemiological data, comorbidity and past clinical history are recorded in addition to the consumption of defined risk medication and proton-pump inhibitors (PPI) during the last 4 weeks.

The Forrest classification is used to describe an ulcer if present at endoscopy and endoscopic modalities for treatment are used according to established recommendations. Surgery or radiological intervention will be applied if needed.

An infection with H. Pylori is diagnosed by different methods including a rapid urease test, culture and serology. If one of these tests is positive, the patient will receive triple therapy. To secure successful eradication patients are tested with 13C UBT (breath test) or HP antigen stool test after 3 months and HP IgG serology after 6 months.

Registration of lowest haemoglobin (Hb) level during hospitalization and an algorithm to treatment with blood transfusion and/or high dose IV iron will be performed to evaluate alternative treatments to blood transfusions alone. Effect of treatment is evaluated at 8 weeks and 6 months. A follow-up gastroscopy and blood test is performed after 2-3 months.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years who consent to be enrolled in the study
* Patients with hematemesis and/or melena, anemia or positiv FOBT that during gastroscopy are diagnosed with ulcer and/or erosions of the ventricle and/or duodenum.
* Gastroscopy must be performed within 24 hours of the findings above.

Exclusion Criteria:

* Patients who do not wish to participate or are not competent to give consent.
* Patients that due to language problems or other reasons do not understand the content of the information about the study.
* Patients with erosions without hematemesis, in whom one diagnose possible bleeding source on colonoscopy.
* Patients with malignant ulcer, ulcer simplex or cameron lesions.

Primary outcomes:
measure: Risk medication in peptic ulcer bleeding
timeFrame: 4 weeks
Secondary outcomes:
measure: PPI prophylaxis in in peptic ulcer bleeding
timeFrame: 4 weeks
measure: H. pylori infection rate
timeFrame: 4 weeks
measure: In vitro H. pylori resistance to antibiotics
timeFrame: 2 weeks
measure: Eradication rate of H. pylori using OAM triple therapy
timeFrame: 6 months
Other outcomes:
measure: Long-term effect of blood transfusion versus treatment with high-dose intravenous iron.
timeFrame: 6 months
Locations:
city: Oslo
country: Norway
facility: Akershus University Hospital
city: Sarpsborg
country: Norway
facility: Ostfold Hospital Trust
state: Østfold
Study officials:
affiliation: Institute of Clinical Medicine, University of Oslo and Akershus University Hospital
name: Jørgen Jahnsen, prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Romstad KK, Detlie TE, Soberg T, Thomas O, Ricanek P, Jahnsen ME, Lerang F, Jahnsen J. Treatment and outcome of gastrointestinal bleeding due to peptic ulcers and erosions - (BLUE study). Scand J Gastroenterol. 2022 Jan;57(1):8-15. doi: 10.1080/00365521.2021.1988701. Epub 2021 Oct 18.
citation: Romstad KK, Detlie TE, Soberg T, Ricanek P, Jahnsen ME, Lerang F, Jahnsen J. Gastrointestinal bleeding due to peptic ulcers and erosions - a prospective observational study (BLUE study). Scand J Gastroenterol. 2020 Oct;55(10):1139-1145. doi: 10.1080/00365521.2020.1819405. Epub 2020 Sep 15.