Bleeding Ulcer and Erosions Study "BLUE Study"

Ostfold Hospital Trust

Status: Completed

Conditions: Peptic Ulcer; Bacterial Infection Due to Helicobacter Pylori (H. Pylori); Bleeding Ulcer

Study type: Observational

Funder types: Other

Identifiers

NCT03367897

1319

Details and patient eligibility

About

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

Full 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.

Enrollment: 543 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

543 participants in 2 patient groups

Bleeding ulcer/erosions

Description:

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 72 hours of the findings above.

Peptic ulcer without bleeding

Description:

Control group for H. pylori will be patients with peptic ulcer without bleeding. These patients are systematically registered at SØ from August 2013 through the ongoing European registration study - HpEuReg study. SØ participate in this study, together with 9 other Norwegian hospitals, which is approved by REK.