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

NCT04296435 | Unknown

• 1 other identifier: IIBSP-FIN-2018-50
• Study Type: observational
• Target: 1,320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Upper Gastrointestinal Hemorrhage

Keywords

Weekend effect; non-varicose upper gastrointestinal bleeding

Outcome Measures

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

  During the years 2017 and 2018

Secondary Outcomes (3)

• Entry Duration

  During the years 2017 and 2018

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

  During the years 2017 and 2018

• Type of endoscopic treatments

  During the years 2017 and 2018

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

RECRUITING

Study Officials

• Luzdivina Perez Garcia

  Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luzdivina Perez Garcia

CONTACT

699940025; Lperez@santpau.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 5, 2020
• Study Start: October 28, 2019
• Primary Completion: October 28, 2021
• Study Completion: December 31, 2021
• Last Updated: March 5, 2020

Record last verified: 2020-03

Locations

ES (1)