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Bleeding Ulcer and Erosions Study "BLUE Study" (BLUE)

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ClinicalTrials.gov Identifier: NCT03367897
Recruitment Status : Completed
First Posted : December 11, 2017
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
University Hospital, Akershus
Information provided by (Responsible Party):
Ostfold Hospital Trust

Study Description
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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
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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 543 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Bleeding Ulcer and Erosions Study "BLUE Study"
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Long-term effect of blood transfusion versus treatment with high-dose intravenous iron. [ Time Frame: 6 months ]
    Blood samples


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367897


Locations
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Norway
Akershus University Hospital
Oslo, Norway
Ostfold Hospital Trust
Sarpsborg, Østfold, Norway
Sponsors and Collaborators
Ostfold Hospital Trust
University Hospital, Akershus
Investigators
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Principal Investigator: Jørgen Jahnsen, prof MD PhD Institute of Clinical Medicine, University of Oslo and Akershus University Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT03367897    
Other Study ID Numbers: 1319
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ostfold Hospital Trust:
Helicobacter pylori
peptic ulcer
erosions
 bleeding
Nsaids
Noac
Additional relevant MeSH terms:
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Bacterial Infections
Peptic Ulcer
Ulcer
Hemorrhage
Pathologic Processes
Bacterial Infections and Mycoses
 Infections
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases