Lower GI BleedingALIBINCT04364412
Acute Lower gastroIntestinal BleedIng (ALIBI Study) in Italy
An observational study of Lower GI Bleeding, run by Valduce Hospital at 1 site in Italy.
Trial summary
Unlike upper GI bleeding, for LGIB there is still a paucity of data on clinical presentation, patient characteristics, pathways of care and outcomes for LGIB patients. In-hospital mortality ranges from 1.2% to 8.8% (2-4), according to retrospective studies, but data from prospective series are still limited (5). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower GI Bleeding
- How many people
- 1,198 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to 18 May 2020
- How long will I take part?
- 15 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
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive, unselected outpatients acutely admitted for LGIB or developing LGIB during hospital stay (inpatients) were eligible for inclusion if they fulfilled the following criteria: i) age > 18 years; ii) recent (< 3 days) onset of overt bleeding with bright or dark blood or clots per rectum or melaena without hematemesis
Who may be able to join
- adult patients with acute lower GI bleeding
Who cannot join
- age below 18 years
- bleeding patients with an upper GI source
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Lower gastroIntestinal BleedIng (ALIBI Study): a Multicentre Prospective, Cohort Study
Unlike upper GI bleeding, for LGIB there is still a paucity of data on clinical presentation, patient characteristics, pathways of care and outcomes for LGIB patients. In-hospital mortality ranges from 1.2% to 8.8% (2-4), according to retrospective studies, but data from prospective series are still limited (5).
Present multicentre, prospective, observational study was designed to explore these areas, to assess variations in practice management and to identify factors associated with patient outcomes.
- Conditions
- Lower GI Bleeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate in patients admitted for acute lower GI bleeding
Number of deaths among the study cohort
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start1 Apr 2019
- Primary completion18 May 2020
- Study completion18 May 2020
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 Lower GI 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,198 participants (actual)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Radaelli, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04364412
- Sponsor's protocol ID
- 70/2018
- Acronym
- ALIBI
- Status last verified
- May 2020
- First submitted
- 6 Apr 2020
- Last updated
- 19 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Radaelli F, Frazzoni L, Repici A, Rondonotti E, Mussetto A, Feletti V, Spada C, Manes G, Segato S, Grassi E, Musso A, Di Giulio E, Coluccio C, Manno M, De Nucci G, Festa V, Di Leo A, Marini M, Ferraris L, Feliziani M, Amato A, Soriani P, Del Bono C, Paggi S, Hassan C, Fuccio L. Clinical management and patient outcomes of acute lower gastrointestinal bleeding. A multicenter, prospective, cohort study. Dig Liver Dis. 2021 Sep;53(9):1141-1147. doi: 10.1016/j.dld.2021.01.002. Epub 2021 Jan 25.
PubMed 33509737
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Lower gastroIntestinal BleedIng (ALIBI Study): a Multicentre Prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT04364412
- Acronym / sponsor ID
- ALIBI / 70/2018
- Conditions
- Lower GI Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,198 participants (actual)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 18 May 2020 (actual)
- Study completion
- 18 May 2020 (actual)
- First posted
- 28 Apr 2020 (actual)
- 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 upper GI bleeding, for LGIB there is still a paucity of data on clinical presentation, patient characteristics, pathways of care and outcomes for LGIB patients. In-hospital mortality ranges from 1.2% to 8.8% (2-4), according to retrospective studies, but data from prospective series are still limited (5).
Present multicentre, prospective, observational study was designed to explore these areas, to assess variations in practice management and to identify factors associated with patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive, unselected outpatients acutely admitted for LGIB or developing LGIB during hospital stay (inpatients) were eligible for inclusion if they fulfilled the following criteria: i) age > 18 years; ii) recent (< 3 days) onset of overt bleeding with bright or dark blood or clots per rectum or melaena without hematemesis
Key inclusion criteria (1 listed)
- adult patients with acute lower GI bleeding
Key exclusion criteria (2 listed)
- age below 18 years
- bleeding patients with an upper GI source
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
Mortality rate in patients admitted for acute lower GI bleeding
Time frame: 4 weeks
Number of deaths among the study cohort
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 19 May 2020.
- Derived from this study: PubMed 33509737Radaelli F, Frazzoni L, Repici A, Rondonotti E, Mussetto A, Feletti V, Spada C, Manes G, Segato S, Grassi E, Musso A, Di Giulio E, Coluccio C, Manno M, De Nucci G, Festa V, Di Leo A, Marini M, Ferraris L, Feliziani M, Amato A, Soriani P, Del Bono C, Paggi S, Hassan C, Fuccio L. Clinical management and patient outcomes of acute lower gastrointestinal bleeding. A multicenter, prospective, cohort study. Dig Liver Dis. 2021 Sep;53(9):1141-1147. doi: 10.1016/j.dld.2021.01.002. Epub 2021 Jan 25.
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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 Lower GI Bleeding, run by Valduce Hospital at 1 site in Italy.
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 2 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 19 May 2020. 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 Italy. 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?
Mortality rate in patients admitted for acute lower GI bleeding (time frame: 4 weeks). 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 NCT04364412, 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 19 May 2020.