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CompletedNCT04364412ALIBIUpdated May 19, 2020

Acute Lower gastroIntestinal BleedIng (ALIBI Study) in Italy

An observational study in Lower GI Bleeding, sponsored by Valduce Hospital. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-19.

Sponsored by Valduce Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,198
Ages
18 Years and older
Sex
All
01

Study 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).

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.

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Conditions studied

  • Lower GI Bleeding
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In context

Gastrointestinal Hemorrhage

339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.

This study's enrollment of 1,198 is above the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

Valduce Hospital is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Inclusion criteria

  • adult patients with acute lower GI bleeding

Exclusion criteria

Exclusion Criteria:

  • age below 18 years
  • bleeding patients with an upper GI source
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,198 participants (actual)
Target follow-up
15 Days
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Mortality rate in patients admitted for acute lower GI bleeding

    Number of deaths among the study cohort

    Time frame: 4 weeks

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Study locations

1 site
  • Valduce Hospital
    Como, 22100, Italy
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04364412
Lead sponsor
Valduce Hospital
Responsible party
Franco Radaelli (Head of Gastroenterology Department, Valduce Hospital) — Principal investigator
First posted
Apr 28, 2020
Start date
Apr 1, 2019
Primary completion
May 18, 2020
Completion
May 18, 2020
Last update
May 19, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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