Acute Upper Gastrointestinal HemorrhageNCT04296435
The Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Upper Gastrointestinal Bleeding
An observational study of Acute Upper Gastrointestinal Hemorrhage, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Upper Gastrointestinal Hemorrhage
- How many people
- 1,320 participants
- Where
- 1 siteSpain
- Study dates
- 28 Oct 2019to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Luzdivina Perez Garcia, 699940025, Lperez@santpau.cat
About this study
Official title: Observational Study About the Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Gastrointestinal Bleeding
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.
- Conditions
- Acute Upper Gastrointestinal Hemorrhage
- Keywords
- Weekend effect, non-varicose upper gastrointestinal bleeding
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital mortality and at 30 days after early gastroscopy will be assessed through clinical history observation, within the study period
Measured: During the years 2017 and 2018
Secondary outcomes (3)
Entry Duration
The time between admission and discharge
Measured: During the years 2017 and 2018
Signs of bleeding activity in a period of less than 12 h. post gastroscopy early.
It will be evaluated using the Rockall scale
Measured: During the years 2017 and 2018
Type of endoscopic treatments
Hemostasis can be performed by applying different techniques or a combination of them
Measured: During the years 2017 and 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start28 Oct 2019
- Primary completion28 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Upper Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luzdivina Perez Garcia, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04296435
- Sponsor's protocol ID
- IIBSP-FIN-2018-50
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study About the Weekend Effect and Its Possible Influence on the Prognosis of Patients With Non-varicose Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT04296435
- Acronym / sponsor ID
- IIBSP-FIN-2018-50
- Conditions
- Acute Upper Gastrointestinal Hemorrhage
- Keywords
- Weekend effect, non-varicose upper gastrointestinal bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 28 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: During the years 2017 and 2018
In-hospital mortality and at 30 days after early gastroscopy will be assessed through clinical history observation, within the study period
3 secondary outcomes
Entry Duration
Time frame: During the years 2017 and 2018
Signs of bleeding activity in a period of less than 12 h. post gastroscopy early.
Time frame: During the years 2017 and 2018
Type of endoscopic treatments
Time frame: During the years 2017 and 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luzdivina Perez Garcia principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Upper Gastrointestinal Hemorrhage, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luzdivina Perez Garcia (699940025, Lperez@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: During the years 2017 and 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.