Risk Assessment After Acute Upper Gastrointestinal Haemorrhage in Cirrhosis

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04235166
• Other study ID #: 302-UGIB
• Status: Recruiting
• Start date: January 10, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2020
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Zheng LU
• Phone: +86-010-66933216
• Email: 13818223446[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Upper Gastrointestinal Hemorrhage
• Cirrhosis, Liver
• Fibrosis
• Gastrointestinal Hemorrhage
• Hemorrhage
• Liver Cirrhosis

Intervention

Other:
• Current risk scores
Current risk scores for assessing the prognosis of acute upper gastrointestinal bleeding in cirrhosis were used.
• New risk scores
New risk scores for assessing the progress of acute upper gastrointestinal bleeding in cirrhosis was used.

Locations

Country	Name	City	State
China	the fifth medical center of PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality within 42 days	Mortality within 42 days were calculated.	42 days
Secondary	Rebleeding rate within 42 days	Rebleeding rate within 42 days were recorded.	42 days