Upper Gastrointestinal HemorrhageNCT01589250
Risk Scoring Systems in Upper GI-haemorrhage
An observational study of Upper Gastrointestinal Hemorrhage, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Use of risk scoring systems in the assessment of patients presenting with upper gastrointestinal haemorrhage is increasing. Comparative studies have intended to identify the system of choice, but the majority of these are characterized by retrospective designs, small sample sizes, low rate of severe bleeding, or low… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Hemorrhage
- How many people
- 831 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Apr 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Data were collected from consecutive patients admitted with UGIH at Odense University Hospital between August 2009 and August 2011. UGIH was defined as history of haematemesis, coffee-ground vomit, or melaena.
Who may be able to join
- One of the following:
- Haematemesis
- Melaena
- Coffee-ground vomit
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Use of risk scoring systems in the assessment of patients presenting with upper gastrointestinal haemorrhage is increasing. Comparative studies have intended to identify the system of choice, but the majority of these are characterized by retrospective designs, small sample sizes, low rate of severe bleeding, or low mortality. The main aim of this study was to identify the optimal scoring system.
- Conditions
- Upper Gastrointestinal Hemorrhage
- Medical subject headings
- Gastrointestinal Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for hospital-based intervention
Need of hospital-based intervention was defined as treatment with blood transfusion, endoscopic therapy, transcatheter arterial embolization (TAE), surgery, or identification of cancer at upper endoscopy.
Measured: 1 month
Secondary outcomes (3)
Identification of low-risk patients
Low-risk patients were defined as patients who did not need hospital-based intervention, and survived more than 30 days from day of admission. Low-risk patients were considered as suitable for early discharge and potential outpatient management.
Measured: 1 month
Rebleeding
Rebleeding was defined as presence of hematemesis, blood per nasogastric tube, or melaena associated with a decline in B-hemoglobin of at least 1mmol/l (not explained by hemodilution) or decline in systolic arterial pressure of at least 20mmHg after the initial bleeding had stopped.
Measured: 1 month
30 day mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startAug 2009
- Primary completionAug 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal HemorrhageStudies 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
- 831 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stig Borbjerg Laursen, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589250
- Sponsor's protocol ID
- SBL-03
- Status last verified
- Apr 2012
- First submitted
- 27 Apr 2012
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Laursen SB, Hansen JM, Schaffalitzky de Muckadell OB. The Glasgow Blatchford score is the most accurate assessment of patients with upper gastrointestinal hemorrhage. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1130-1135.e1. doi: 10.1016/j.cgh.2012.06.022. Epub 2012 Jul 16.
PubMed 22801061
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Scoring Systems in Upper GI-haemorrhage
- ClinicalTrials.gov ID
- NCT01589250
- Acronym / sponsor ID
- SBL-03
- Conditions
- Upper Gastrointestinal Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 1 May 2012 (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.
Use of risk scoring systems in the assessment of patients presenting with upper gastrointestinal haemorrhage is increasing. Comparative studies have intended to identify the system of choice, but the majority of these are characterized by retrospective designs, small sample sizes, low rate of severe bleeding, or low mortality. The main aim of this study was to identify the optimal scoring system.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data were collected from consecutive patients admitted with UGIH at Odense University Hospital between August 2009 and August 2011. UGIH was defined as history of haematemesis, coffee-ground vomit, or melaena.
Key inclusion criteria (4 listed)
- Haematemesis
- Melaena
- Coffee-ground vomit
Key exclusion criteria (0 listed)
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
Need for hospital-based intervention
Time frame: 1 month
Need of hospital-based intervention was defined as treatment with blood transfusion, endoscopic therapy, transcatheter arterial embolization (TAE), surgery, or identification of cancer at upper endoscopy.
3 secondary outcomes
Identification of low-risk patients
Time frame: 1 month
Rebleeding
Time frame: 1 month
30 day mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
- Derived from this study: PubMed 22801061Laursen SB, Hansen JM, Schaffalitzky de Muckadell OB. The Glasgow Blatchford score is the most accurate assessment of patients with upper gastrointestinal hemorrhage. Clin Gastroenterol Hepatol. 2012 Oct;10(10):1130-1135.e1. doi: 10.1016/j.cgh.2012.06.022. Epub 2012 Jul 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Hemorrhage, run by Odense University Hospital at 1 site in Denmark.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Need for hospital-based intervention (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01589250, which also lists 1 linked publication.
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 1 May 2012.