Gastrointestinal Bleeding Management

Management of Patients With Gastrointestinal Bleeding - a Prospective Single Center Registry Study

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.

Study Overview

• Status: Unknown
• Conditions: Gastrointestinal Bleeding

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 Type: Observational
• Enrollment (Anticipated): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients that will be admitted to our hospital with a gastrointestinal bleeding.

Description

Inclusion Criteria:

• All patients with suspicion or symptoms of gastrointestinal bleeding.

Exclusion Criteria:

• Patients younger than 18 years

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr. Horst Schmidt Klinik GmbH
• Investigators: Study Director: Ralf Kiesslich, Professor, HSK Clinic Wiesbaden, Department of Internal Medicine II

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Estimate): July 7, 2015
• Last Update Submitted That Met QC Criteria: July 6, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: HSK006