NCT04364412

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,198

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

1.1 years

First QC Date

April 6, 2020

Last Update Submit

May 18, 2020

Conditions

Lower GI Bleeding

Outcome Measures

Primary Outcomes (1)

  • Mortality rate in patients admitted for acute lower GI bleeding

    Number of deaths among the study cohort

    4 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • adult patients with acute lower GI bleeding

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valduce Hospital

Como, 22100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 33509737DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gastroenterology Department

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 28, 2020

Study Start

April 1, 2019

Primary Completion

May 18, 2020

Study Completion

May 18, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

IT(1)