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Completed

NCT Number: NCT03367897

Bleeding Ulcer and Erosions Study "BLUE Study"

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

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Key information

Conditions

Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Bleeding Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Hemorrhage Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peptic Ulcer Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ostfold Hospital Trust, Sarpsborg, Østfold fylke, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Risk medication in peptic ulcer bleeding

    Time frame: 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 outcomes

  1. PPI prophylaxis in in peptic ulcer bleeding

    Time frame: 4 weeks

    Any use of PPI inhibitors during the last four weeks before the bleeding episode.

  2. H. pylori infection rate

    Time frame: 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.

  3. In vitro H. pylori resistance to antibiotics

    Time frame: 2 weeks

    In vitro metronidazole susceptibility testing

  4. Eradication rate of H. pylori using OAM triple therapy

    Time frame: 6 months

    3 months: 13C UBT (breath test) or HP antigen stool test. 6 months: ELISA IgG anti-HP antibodies

Other outcomes

  1. Long-term effect of blood transfusion versus treatment with high-dose intravenous iron.

    Time frame: 6 months

    Blood samples

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Collaborators

  • University Hospital, Akershus

Registry information

Acronym: BLUE

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Dec 11, 2017
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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