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Risk Assessment After Acute Upper Gastrointestinal Haemorrhage in Cirrhosis

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04235166
Enrollment
500
Registered
2020-01-21
Start date
2020-01-10
Completion date
2020-06-30
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Upper Gastrointestinal Hemorrhage, Cirrhosis, Liver

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.

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.

Interventions

OTHERCurrent risk scores

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

OTHERNew risk scores

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

Sponsors

Affiliated Hospital to Academy of Military Medical Sciences
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mortality within 42 days42 daysMortality within 42 days were calculated.

Secondary

MeasureTime frameDescription
Rebleeding rate within 42 days42 daysRebleeding rate within 42 days were recorded.

Countries

China

Contacts

Primary ContactZheng LU
13818223446@163.com+86-010-66933216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026