Gastrointestinal Bleeding Management

Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02403076
• Other study ID #: HSK006
• Status: Active, not recruiting
• Phase: N/A
• First received: March 12, 2015
• Last updated: July 6, 2015
• Start date: January 2015

Study information

• Verified date: July 2015
• Source: Dr. Horst Schmidt Klinik GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with suspicion or symptoms of gastrointestinal bleeding.

Exclusion Criteria:

• Patients younger than 18 years

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Horst Schmidt Klinik GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No