Gastrointestinal BleedingNCT02403076
Gastrointestinal Bleeding Management
An observational study of Gastrointestinal Bleeding, run by Dr. Horst Schmidt Klinik GmbH.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Bleeding
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jan 2018
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients that will be admitted to our hospital with a gastrointestinal bleeding.
Who may be able to join
- All patients with suspicion or symptoms of gastrointestinal bleeding.
Who cannot join
- Patients younger than 18 years
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastrointestinal Bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ralf Kiesslich, Professor, Study director, HSK Clinic Wiesbaden, Department of Internal Medicine II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403076
- Sponsor's protocol ID
- HSK006
- Status last verified
- Jul 2015
- First submitted
- 12 Mar 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients With Gastrointestinal Bleeding - a Prospective Single Center Registry Study
- ClinicalTrials.gov ID
- NCT02403076
- Acronym / sponsor ID
- HSK006
- Conditions
- Gastrointestinal Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jan 2018 (estimated)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that will be admitted to our hospital with a gastrointestinal bleeding.
Key inclusion criteria (1 listed)
- All patients with suspicion or symptoms of gastrointestinal bleeding.
Key exclusion criteria (1 listed)
- Patients younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time of endoscopy
Time frame: 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.
2 secondary outcomes
Follow up endoscopy (how many patients with gastrointestinal bleeding receive follow-up endoscopy )
Time frame: 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)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Kiesslich, Professor study director
HSK Clinic Wiesbaden, Department of Internal Medicine II
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Bleeding, run by Dr. Horst Schmidt Klinik GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of endoscopy (time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2015.