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Status unknownNCT04296435Updated Mar 5, 2020

The Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Upper Gastrointestinal Bleeding

An observational study in Acute Upper Gastrointestinal Hemorrhage, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-05.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,320
Ages
18 Years and older
Sex
All
01

Study summary

The hypothesis is that the mortality of patients with non-varicose upper gastrointestinal bleeding after performing early gastroscopy who are admitted on weekends and night hours is higher than those admitted on weekdays or during daytime hours.

Read the detailed description

The aim of the study is to evaluate the impact of the schedule (day or night) and the day of admission (working or weekend / night) on the mortality of patients with non-varicose upper gastrointestinal bleeding after performing an early gastroscopy.

A retrospective observational study will be carried out in patients admitted to the bleeding unit of the Santa Creu I Sant Pau Hospital, where we observed hospital mortality and 30 days after performing an early gastroscopy, the duration of admission, signs of hemorrhagic activity in a period of less than 12 h. After early gastroscopy and types of endoscopic treatments, data will be collected by reviewing medical records.

The number of patients expected to be included in this study is 1320 patients. Patients will be included the day they enter the bleeding unit for an early gastroscopy.

02

Conditions studied

  • Acute Upper Gastrointestinal Hemorrhage

Keywords

  • Weekend effect
  • non-varicose upper gastrointestinal bleeding
03

In context

Gastrointestinal Hemorrhage

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

This study's planned enrollment of 1,320 is above the median of 200 across 116 observational studies indexed under Gastrointestinal Hemorrhage.

Browse Gastrointestinal Hemorrhage studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with non-varicose upper gastrointestinal bleeding and admitted to the Bleeding Unit of the Santa Creu and Sant Pau hospital during 2017 and 2018 to perform an early gastroscopy. In addition, patients must meet the following inclusion and exclusion criteria.

Inclusion criteria

  • Patients older than 18 years.
  • Patients admitted to the Bleeding Unit with a diagnosis of upper gastrointestinal bleeding.
  • Patients who have undergone an early endoscopy to determine the source of bleeding.
  • In case of readmissions during the study period, we consider only the admission closest to his death or discharge.

Exclusion criteria

Exclusion criteria:

  • Patients diagnosed with gastrointestinal bleeding varicose.
  • Patients who present with gastrointestinal bleeding and did not perform early gastroscopy (during the first 24 hours)
  • Patients admitted for different medical conditions, who developed upper gastrointestinal bleeding during the course of hospital stay.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,320 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Mortality

    In-hospital mortality and at 30 days after early gastroscopy will be assessed through clinical history observation, within the study period

    Time frame: During the years 2017 and 2018

Secondary outcomes

  1. Entry Duration

    The time between admission and discharge

    Time frame: During the years 2017 and 2018

  2. Signs of bleeding activity in a period of less than 12 h. post gastroscopy early.

    It will be evaluated using the Rockall scale

    Time frame: During the years 2017 and 2018

  3. Type of endoscopic treatments

    Hemostasis can be performed by applying different techniques or a combination of them

    Time frame: During the years 2017 and 2018

07

Study locations

1 of 1 sites recruiting
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 08025, Spain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04296435
Lead sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Responsible party
Sponsor
First posted
Mar 5, 2020
Start date
Oct 28, 2019
Primary completion
Oct 28, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Mar 5, 2020

Study contacts

Luzdivina Perez Garcia
Contact
Lperez@santpau.cat
699940025
Luzdivina Perez Garcia
principal investigator · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Oversight

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

Not currently enrolling

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

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