Risk Assessment After Acute Upper Gastrointestinal Haemorrhage in Cirrhosis

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: Unknown
• Conditions: Cirrhosis, Liver; Acute Upper Gastrointestinal Hemorrhage
• Intervention / Treatment: Other: Current risk scores; Other: New risk scores

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: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Zheng LU; Phone Number: +86-010-66933216; Email: 13818223446@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100039
      • Recruiting
      • The Fifth Medical Center of PLA General Hospital
      • Contact: Zheng Lu, M.D.; Phone Number: +86-010-66933216; Email: 13818223446@163.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Mortality within 42 days	Mortality within 42 days were calculated.	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rebleeding rate within 42 days	Rebleeding rate within 42 days were recorded.	42 days

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Principal Investigator: Zheng Lu, Beijing 302 Hospital

Publications and helpful links

General Publications

• Saltzman JR, Tabak YP, Hyett BH, Sun X, Travis AC, Johannes RS. A simple risk score accurately predicts in-hospital mortality, length of stay, and cost in acute upper GI bleeding. Gastrointest Endosc. 2011 Dec;74(6):1215-24. doi: 10.1016/j.gie.2011.06.024. Epub 2011 Sep 10.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Fibrosis; Hemorrhage; Liver Cirrhosis; Gastrointestinal Hemorrhage
• Other Study ID 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