Clinical trial NCT02403076: Gastrointestinal Bleeding Management
Official title: Management of Patients With Gastrointestinal Bleeding - a Prospective Single Center Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Bleeding
Lead sponsor: Dr. Horst Schmidt Klinik GmbH
Sponsor class: INDUSTRY
First posted: 2015-03-31
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that will be admitted to our hospital with a gastrointestinal bleeding.

Brief summary: Unlike the management of patients with various forms of accidents (e.g. polytrauma), only a few data exists for the emergency management of patients with acute gastrointestinal bleeding. The aim of our study is to develop optimal diagnostic and therapeutic algorithms for the management of acute upper and lower gastrointestinal bleedings.

Detailed description: Acute upper gastrointestinal bleeding is a common medical emergency. Up to 15% of patients still die worldwide. The gastroduodenal ulcer disease is the most common cause of gastrointestinal bleeding. Even lower gastrointestinal bleeding occurs especially in patients of older age.

The goal of our data acquisition and evaluation is to learn whether existing diagnostic or therapeutic procedures are of relevance in the management of acute gastrointestinal bleedings. Unlike the management of patients with various forms of accidents (e.g. polytrauma), only a few data exists on patients with acute gastrointestinal bleedings. The aim of our study is to develop optimal diagnostic and therapeutic algorithms of acute gastrointestinal bleeding. Therefore our prospective data registry should answer different questions:

When is the right time for a gastroscopy or colonoscopy? Should every patient with a suspected gastrointestinal bleeding receive endoscopy? Which clinical und laboratory findings influence the success of therapy? Does endoscopic procedures have an influence on the length of hospital stay?

Against this background we will record treatment findings separately. This includes clinical (e.g. age, sex, date of admission, department of admission, onset of symptoms), laboratory (e.g. blood count), history of medications (e.g. new anticoagulation's) and endoscopic findings (e.g. active bleeding). Furthermore the length of inhospital stay will be recorded.

Participants will be followed for the duration of hospital stay, an expected average of 7 days.

Eligibility criteria: Inclusion Criteria:

* All patients with suspicion or symptoms of gastrointestinal bleeding.

Exclusion Criteria:

* Patients younger than 18 years

Primary outcomes:
measure: Time of endoscopy
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Secondary outcomes:
measure: Follow up endoscopy (how many patients with gastrointestinal bleeding receive follow-up endoscopy )
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
measure: Endoscopic therapies (whether taking anticoagulants have an impact on the need for endoscopic therapies)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Other outcomes:
Locations:
Study officials:
affiliation: HSK Clinic Wiesbaden, Department of Internal Medicine II
name: Ralf Kiesslich, Professor
role: STUDY_DIRECTOR
References: