NCT04235166

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 24, 2020

Status Verified

January 1, 2020

Enrollment Period

5 months

First QC Date

January 16, 2020

Last Update Submit

February 20, 2020

Conditions

Cirrhosis, LiverAcute Upper Gastrointestinal Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Mortality within 42 days

    Mortality within 42 days were calculated.

    42 days

Secondary Outcomes (1)

  • Rebleeding rate within 42 days

    42 days

Study Arms (1)

Patient cohort

Different risk score was used to assess the prognosis of acute upper gastrointestinal bleeding in cirrhosis.

Other: Current risk scoresOther: New risk scores

Interventions

Current risk scoresOTHER

Current risk scores for assessing the prognosis of acute upper gastrointestinal bleeding in cirrhosis were used.

Patient cohort
New risk scoresOTHER

New risk scores for assessing the progress of acute upper gastrointestinal bleeding in cirrhosis was used.

Patient cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Unfit for resuscitation
  • Pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the fifth medical center of PLA General Hospital

Beijing, Beijing Municipality, 100039, China

RECRUITING

Related 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.

    PMID: 21907980BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zheng Lu

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng LU

CONTACT

+86-010-6693321613818223446@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 21, 2020

Study Start

January 10, 2020

Primary Completion

May 31, 2020

Study Completion

June 30, 2020

Last Updated

February 24, 2020

Record last verified: 2020-01

Locations

CN(1)