Acute Lower gastroIntestinal BleedIng (ALIBI Study) in Italy

Lower GI Bleeding Clinical Trial

— ALIBI  

Official title:

Acute Lower gastroIntestinal BleedIng (ALIBI Study): a Multicentre Prospective, Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364412
• Other study ID #: 70/2018
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: May 18, 2020

Study information

• Verified date: May 2020
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1198
• Est. completion date: May 18, 2020
• Est. primary completion date: May 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients with acute lower GI bleeding

Exclusion Criteria:

• age below 18 years

• bleeding patients with an upper GI source

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Lower GI Bleeding

Locations

Country	Name	City	State
Italy	Valduce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate in patients admitted for acute lower GI bleeding	Number of deaths among the study cohort	4 weeks