Risk Assessment After Acute Upper Gastrointestinal Haemorrhage in Cirrhosis

February 20, 2020 updated by: Affiliated Hospital to Academy of Military Medical Sciences

A Simple Risk Score to Assess Prognosis of Acute Upper Gastrointestinal Bleeding in Cirrhosis

In previous studies, the investigators used retrospective analysis of cases of acute upper gastrointestinal bleeding in patients with liver cirrhosis from the Fifth Medical Center of the General Hospital of Beijing PLA, China from January 2018 to May 2019. The investigators performed univariate and multivariate analyses of rebleeding risk and death risk based on all data. Then, based on the analysis of 85% of the sampled data, the investigators randomly selected 85% of the patient data to build a model, and then used the remaining 15% of the patient data for model validation. Re-bleeding risk scores and death risk scores were established, respectively.

This study intends to prospectively verify the two risk scoring systems described above. After statistical calculations, about 500 patients with liver cirrhosis who plan to undergo emergency gastroscopy for acute upper gastrointestinal bleeding within the next 5 months at the Fifth Medical Center of Beijing General Hospital of China performed in adult patients. The investigators will exclude patients with incomplete or lost follow-up records. Perform patient self-control,using the existing upper gastrointestinal bleeding risk scores (AIMS65, Rockall, and Blatchford) and the previous scoring system model separately, compared with the actual rebleeding rate and mortality for comparison. To verify and revise the rebleeding risk score and death risk score that the investigators constructed earlier.The data were statistical processed by a professional statistician.

The establishment of an acute upper gastrointestinal bleeding rebleeding and death risk scoring system for patients with liver cirrhosis can help distinguish patients with high or low risk of rebleeding or death to determine the patient's treatment needs.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In previous studies, the investigators used retrospective analysis of cases of acute upper gastrointestinal bleeding in patients with liver cirrhosis from the Fifth Medical Center of the General Hospital of Beijing PLA, China from January 2018 to May 2019. The survey and return visits were completed by the patient's clinician, and the subject researcher was responsible for reviewing and including a complete questionnaire for eligible patients. The database includes demographic information, vital signs and other key clinical manifestations, endoscopic findings, laboratory test results, imaging studies and complications, and rebleeding and deaths within 42 days. Covers known risk factors for rebleeding and death.

First, the investigators performed univariate and multivariate analyses of rebleeding risk and death risk based on all data. Second, based on the analysis of 85% of the sampled data, the investigators randomly selected 85% of the patient data to build a model, and then used the remaining 15% of the patient data for model validation. Re-bleeding risk scores and death risk scores were established respectively.

This study intends to prospectively verify the two risk scoring systems described above. After statistical calculations, about 500 patients with liver cirrhosis who plan to undergo emergency gastroscopy for acute upper gastrointestinal bleeding within the next 5 months at the Fifth Medical Center of Beijing General Hospital of China Performed in adult patients. the investigators will exclude patients with incomplete or lost follow-up records. One researcher was responsible for patient identification and data collection during the initial review, and one researcher performed subsequent data entry, which was statistical processed by a professional statistician.

Perform patient self-control,using the existing upper gastrointestinal bleeding risk scores (AIMS65, Rockall, and Blatchford) and the previous scoring system model separately, compared with the actual rebleeding rate and mortality for comparison. To verify and revise the rebleeding risk score and death risk score that the investigators constructed earlier.

The establishment of an acute upper gastrointestinal bleeding rebleeding and death risk scoring system for patients with liver cirrhosis can help distinguish patients with high or low risk of rebleeding or death to determine the patient's treatment needs.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Recruiting
        • The Fifth Medical Center of PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically proven cirrhosis or clinical and ultrasonographic data compatible with the diagnosis of cirrhosis were included.

Description

Inclusion Criteria:

  • Patients with histologically proven cirrhosis or clinical and ultrasonographic data compatible with the diagnosis of cirrhosis
  • Above 18 years old patients
  • Clinical evidence of bleeding (hematemesis and/or melena) during the previous 24 hours
  • Undergo the emergency endoscopy within 2 hours at admittance to emergency room or in the general ward from the initial evaluation
  • Who agree to participate in the study

Exclusion Criteria:

  • Unfit for resuscitation
  • Pregnancy and lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient cohort
Different risk score was used to assess the prognosis of acute upper gastrointestinal bleeding in cirrhosis.
Other: Current risk scores
Current risk scores for assessing the prognosis of acute upper gastrointestinal bleeding in cirrhosis were used.
Other: New risk scores
New risk scores for assessing the progress of acute upper gastrointestinal bleeding in cirrhosis was used.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mortality within 42 days
Time Frame: 42 days
Mortality within 42 days were calculated.
42 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rebleeding rate within 42 days
Time Frame: 42 days
Rebleeding rate within 42 days were recorded.
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiliated Hospital to Academy of Military Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zheng Lu, Beijing 302 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 302-UGIB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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