Acute Variceal BleedingNCT05613309
Clinical Characteristics Analysis and Prediction Model Establishment of Fatal Esophageal and Gastric Variceal Bleeding
An observational study of Acute Variceal Bleeding, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
The purpose of this study is to analyze the clinical characteristics of patients with fatal acute variceal bleeding (AVB) and establish a mortality risk prediction model to identify patients at high risk of death after admission, so as to guide clinical practice, further optimize the allocation of emergency resources… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Variceal Bleeding
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Oct 2023
- 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 with acute varicose hemorrhage in Renmin Hospital of Wuhan University in recent 10 years
Who may be able to join
- History of cirrhosis/previous history of endoscopic varicose veins/undiagnosed liver disease but signs related to liver disease, hematemesis or melena; The diagnosis of cirrhosis is based on liver biopsy or the usual clinical and radiological criteria;
- AVB was confirmed by endoscopy without special medical history;
Who cannot join
- Patients who cannot obtain complete data (vital signs, medical history, laboratory tests and other data are seriously missing);
- Patients with upper gastrointestinal bleeding have no evidence of AVB.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mingkai Chen
Wuhan, Hubei, 430060
Mingkai Chen, PHD, + 86 13720330580, chenmingkai@whu.edu.cn
About this study
The purpose of this study is to analyze the clinical characteristics of patients with fatal acute variceal bleeding (AVB) and establish a mortality risk prediction model to identify patients at high risk of death after admission, so as to guide clinical practice, further optimize the allocation of emergency resources, and further reduce the mortality of AVB patients.
Read the detailed description
How to predict adverse outcomes of acute variceal bleeding and identify high-risk patients remains unclear. Most studies related to risk factors for adverse outcomes in AVB patients took 5 days and 6 weeks as time nodes, and the main outcome indicators were the rebleeding rate and mortality rate at 5 days and 6 weeks. However, some patients admitted to hospital may suffer death within a short period of time ,the investigators will define AVB patients at high risk of death in several hours after admission as fatal acute variceal bleeding.To identify such patients and give more positive treatment can further reduce the mortality of AVB. Such risk stratification can be used to further guide the rational allocation of emergency resources, improve the efficacy of medical resources. This study intends to retrospectively collect the clinical data of AVB patients in Renmin Hospital of Wuhan University, analyze the risk factors for death after admission, establish a mortality risk prediction model, and compare and validate the new model and the scoring model to be verified.
- Conditions
- Acute Variceal Bleeding
- Keywords
- Acute variceal bleeding, Mortality risk prediction model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with acute varicose hemorrhage in Renmin Hospital of Wuhan University in recent 10 years | In this study, patients with liver cirrhosis and acute variceal bleeding in Renmin Hospital of Wuhan University in the past 10 years will be selected as the research objects. Patients will be divided into survival and death groups according to whether they died 6 hours after admission. The differences in clinical data between the two groups will be compared and analyzed to decide the risk factors for early death and establish a mortality risk prediction model. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute death occurred after admission
Death in patients with acute varicose bleeding in cirrhosis occurs within a short time (initially defined as less than 6 hours after admission)
Measured: Six hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Dec 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Variceal BleedingStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ChenMingkai, Renmin Hospital of Wuhan University
- Investigators
- Mingkai Chen, PHD, Study director, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613309
- Sponsor's protocol ID
- WDRY2022-K204
- Status last verified
- Feb 2023
- First submitted
- 4 Nov 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics Analysis and Prediction Model Establishment of Fatal Esophageal and Gastric Variceal Bleeding
- ClinicalTrials.gov ID
- NCT05613309
- Acronym / sponsor ID
- WDRY2022-K204
- Conditions
- Acute Variceal Bleeding
- Keywords
- Acute variceal bleeding, Mortality risk prediction model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 14 Nov 2022 (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 purpose of this study is to analyze the clinical characteristics of patients with fatal acute variceal bleeding (AVB) and establish a mortality risk prediction model to identify patients at high risk of death after admission, so as to guide clinical practice, further optimize the allocation of emergency resources, and further reduce the mortality of AVB patients.
Detailed description
How to predict adverse outcomes of acute variceal bleeding and identify high-risk patients remains unclear. Most studies related to risk factors for adverse outcomes in AVB patients took 5 days and 6 weeks as time nodes, and the main outcome indicators were the rebleeding rate and mortality rate at 5 days and 6 weeks. However, some patients admitted to hospital may suffer death within a short period of time ,the investigators will define AVB patients at high risk of death in several hours after admission as fatal acute variceal bleeding.To identify such patients and give more positive treatment can further reduce the mortality of AVB. Such risk stratification can be used to further guide the rational allocation of emergency resources, improve the efficacy of medical resources. This study intends to retrospectively collect the clinical data of AVB patients in Renmin Hospital of Wuhan University, analyze the risk factors for death after admission, establish a mortality risk prediction model, and compare and validate the new model and the scoring model to be verified.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute varicose hemorrhage in Renmin Hospital of Wuhan University in recent 10 years | – | –In this study, patients with liver cirrhosis and acute variceal bleeding in Renmin Hospital of Wuhan University in the past 10 years will be selected as the research objects. Patients will be divided into survival and death groups according to whether they died 6 hours after admission. The differences in clinical data between the two groups will be compared and analyzed to decide the risk factors for early death and establish a mortality risk prediction model. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute varicose hemorrhage in Renmin Hospital of Wuhan University in recent 10 years
Key inclusion criteria (2 listed)
- History of cirrhosis/previous history of endoscopic varicose veins/undiagnosed liver disease but signs related to liver disease, hematemesis or melena; The diagnosis of cirrhosis is based on liver biopsy or the usual clinical and radiological criteria;
- AVB was confirmed by endoscopy without special medical history;
Key exclusion criteria (2 listed)
- Patients who cannot obtain complete data (vital signs, medical history, laboratory tests and other data are seriously missing);
- Patients with upper gastrointestinal bleeding have no evidence of AVB.
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
Acute death occurred after admission
Time frame: Six hours after admission
Death in patients with acute varicose bleeding in cirrhosis occurs within a short time (initially defined as less than 6 hours after admission)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Variceal Bleeding
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Timing of Endoscopy in Cirrhotic Patients With Acute Variceal Bleeding
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Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction
Liver Cirrhosis
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Keverprazan vs Pantoprazole for the Treatment of ANVUGIB
Non-variceal Upper Gastrointestinal Bleeding
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PPIs and In-Hospital Morbidity in Acute Variceal Bleeding With Chronic Liver Disease
Morbidity
Not yet recruitingObservational study
Acute Kidney Injury in Upper GI Bleeding Patients
Upper Gastrointestinal Bleeding, Acute Kidney Injury
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.
Mingkai Chen, PHD study director
Renmin Hospital of Wuhan University
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 Variceal Bleeding, run by Renmin Hospital of Wuhan University at 1 site in China.
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 2 inclusion and 2 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 3 Feb 2023. 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 China. 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 Mingkai Chen, PHD (+8613720330580, chenmingkai@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute death occurred after admission (time frame: Six hours after admission). 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 3 Feb 2023.