Bleeding Ulcer and Erosions Study "BLUE Study"

NCT03367897 | Completed DMC

• 1 other identifier: 1319
• Study Type: observational
• Target: 543
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Helicobacter pylori; peptic ulcer; erosions; bleeding; Nsaids; Noac

Outcome Measures

Primary Outcomes (1)

• Risk medication in peptic ulcer bleeding

  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.

  4 weeks

Secondary Outcomes (4)

• PPI prophylaxis in in peptic ulcer bleeding

  4 weeks

• H. pylori infection rate

  4 weeks

• In vitro H. pylori resistance to antibiotics

  2 weeks

• Eradication rate of H. pylori using OAM triple therapy

  6 months

Other Outcomes (1)

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

  6 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ostfold Hospital Trust: lead
• University Hospital, Akershus: collaborator

Study Sites (2)

Akershus University Hospital

Oslo, Norway

Location

Ostfold Hospital Trust

Sarpsborg, Østfold fylke, Norway

Location

Related Publications (3)

• Romstad KK, Thomas O, Soberg T, Detlie TE, Ricanek P, Jahnsen ME, Lerang F, Jahnsen J. High consumption of risk medication and underutilization of proton pump inhibitors among patients with upper gastrointestinal bleeding due to peptic ulcers and erosions (BLUE study). Scand J Gastroenterol. 2026 Jan;61(1):44-52. doi: 10.1080/00365521.2025.2594780. Epub 2025 Dec 16.

  PMID: 41400236 DERIVED

• 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.

  PMID: 34663154 DERIVED

• 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.

  PMID: 32931710 DERIVED

MeSH Terms

Conditions

Peptic Ulcer; Hemorrhage

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jørgen Jahnsen, prof MD PhD

  Institute of Clinical Medicine, University of Oslo and Akershus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: December 11, 2017
• Study Start: March 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2019
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)