Bleeding Ulcer and Erosions Study "BLUE Study"

Peptic Ulcer Clinical Trial

— BLUE  

Official title:

Bleeding Ulcer and Erosions Study "BLUE Study"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03367897
• Other study ID #: 1319
• Status: Completed
• Start date: March 2015
• Est. completion date: July 2019

Study information

• Verified date: November 2019
• Source: Ostfold Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: July 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
• Bacterial Infections
• Bleeding Ulcer
• Hemorrhage
• Peptic Ulcer
• Ulcer

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Oslo
Norway	Ostfold Hospital Trust	Sarpsborg	Østfold

Sponsors (2)

Lead Sponsor	Collaborator
Ostfold Hospital Trust	University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long-term effect of blood transfusion versus treatment with high-dose intravenous iron.	Blood samples	6 months
Primary	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	PPI prophylaxis in in peptic ulcer bleeding	Any use of PPI inhibitors during the last four weeks before the bleeding episode.	4 weeks
Secondary	H. pylori infection rate	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.	4 weeks
Secondary	In vitro H. pylori resistance to antibiotics	In vitro metronidazole susceptibility testing	2 weeks
Secondary	Eradication rate of H. pylori using OAM triple therapy	3 months: 13C UBT (breath test) or HP antigen stool test. 6 months: ELISA IgG anti-HP antibodies	6 months