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

Acute Upper Gastrointestinal Hemorrhage Clinical Trial

Official title:

Observational Study About the Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Gastrointestinal Bleeding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04296435
• Other study ID #: IIBSP-FIN-2018-50
• Status: Recruiting
• Start date: October 28, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Luzdivina Perez Garcia
• Phone: 699940025
• Email: Lperez[@]santpau.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1320
• Est. completion date: December 31, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Acute Upper Gastrointestinal Hemorrhage
• Gastrointestinal Hemorrhage
• Hemorrhage

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Entry Duration	The time between admission and discharge	During the years 2017 and 2018
Secondary	Signs of bleeding activity in a period of less than 12 h. post gastroscopy early.	It will be evaluated using the Rockall scale	During the years 2017 and 2018
Secondary	Type of endoscopic treatments	Hemostasis can be performed by applying different techniques or a combination of them	During the years 2017 and 2018