Bleeding Ulcer and Erosions Study "BLUE Study"

Sponsor

Ostfold Hospital Trust (Other)

Overall Status

Completed

CT.gov ID

NCT03367897

Collaborator

University Hospital, Akershus (Other)

543

Enrollment

Locations

Actual Duration (Months)

271.5

Patients Per Site

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Peptic Ulcer Bleeding Ulcer

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

543 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Bleeding Ulcer and Erosions Study "BLUE Study"

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Bleeding ulcer/erosions 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 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.

Outcome Measures

Primary Outcome Measures

Risk medication in peptic ulcer bleeding [4 weeks]
Any use of NSAIDs (non-selective NSAIDs and / or COX-2 inhibitors), acetylsalicylic acid (ASA), other antiplatelet agents (non ASA antiplatelet agents), warfarin, DOAC, LMWH, H2 blockers and proton pump inhibitors during the last four weeks before the bleeding episode.

Secondary Outcome Measures

PPI prophylaxis in in peptic ulcer bleeding [4 weeks]
Any use of PPI inhibitors during the last four weeks before the bleeding episode.
H. pylori infection rate [4 weeks]
Gastric biopsies: 2 from the antrum and 2 from the corpus for culture, 1 the antrum and 1 from the corpus for rapid urease test (BIOHIT). Blood test sampling for ELISA IgG anti-HP antibodies.
In vitro H. pylori resistance to antibiotics [2 weeks]
In vitro metronidazole susceptibility testing
Eradication rate of H. pylori using OAM triple therapy [6 months]
3 months: 13C UBT (breath test) or HP antigen stool test. 6 months: ELISA IgG anti-HP antibodies

Other Outcome Measures

Long-term effect of blood transfusion versus treatment with high-dose intravenous iron. [6 months]
Blood samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.