Gastrointestinal Bleeding Management

• Conditions: Gastrointestinal Bleeding

• Registration Number: NCT02403076
• Lead Sponsor: Dr. Horst Schmidt Klinik GmbH

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-06
• Last Update Posted: 2015-07-07
• Primary Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All patients with suspicion or symptoms of gastrointestinal bleeding.

Exclusion Criteria

• Patients younger than 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time of endoscopy	Participants will be followed for the duration of hospital stay, an expected average of 7 days.	The aim of this primary endpoint should reflect whether the timing of endoscopic diagnosis after admission has an impact on the length hospital stay.

Secondary Outcome Measures

Name	Time	Method
Follow up endoscopy (how many patients with gastrointestinal bleeding receive follow-up endoscopy )	Participants will be followed for the duration of hospital stay, an expected average of 7 days.	It will be noted how many patients with gastrointestinal bleeding receive follow-up endoscopy with therapeutic procedures.
Endoscopic therapies (whether taking anticoagulants have an impact on the need for endoscopic therapies)	Participants will be followed for the duration of hospital stay, an expected average of 7 days.	It should be study whether taking anticoagulants have an impact on the need for endoscopic therapies.