Risk Assessment After Acute Upper Gastrointestinal Haemorrhage in Cirrhosis
NCT ID: NCT04235166
Last Updated: 2020-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2020-01-10
2020-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient cohort
Different risk score was used to assess the prognosis of acute upper gastrointestinal bleeding in cirrhosis.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy and lactation
18 Years
ALL
No
Sponsors
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Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Zheng Lu
Role: PRINCIPAL_INVESTIGATOR
Beijing 302 Hospital
Locations
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the fifth medical center of PLA General Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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302-UGIB
Identifier Type: -
Identifier Source: org_study_id
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