Acute Lower gastroIntestinal BleedIng (ALIBI Study) in Italy (ALIBI)

May 18, 2020 updated by: Franco Radaelli, Valduce Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1198

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Como, Italy, 22100
        • Valduce Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • adult patients with acute lower GI bleeding

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate in patients admitted for acute lower GI bleeding
Time Frame: 4 weeks
Number of deaths among the study cohort
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valduce Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

May 18, 2020

Study Completion (ACTUAL)

May 18, 2020

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 26, 2020

First Posted (ACTUAL)

April 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 18, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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