NCT04235166

Risk Assessment After Acute Upper Gastrointestinal Haemorrhage in Cirrhosis

Status unknown Last updated 24 February 2020

What this trial tests

trial testing Current risk scores in Cirrhosis, Liver in 500 participants. Status unknown.

Timeline

10 January 2020

Primary endpoint
31 May 2020

30 June 2020

Quick facts

Lead sponsor	Affiliated Hospital to Academy of Military Medical Sciences
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	500
Start date	10 January 2020
Primary completion	31 May 2020
Estimated completion	30 June 2020
Sites	1 location across China

Drugs / interventions tested

• Current risk scores
• New risk scores

Conditions studied

• Cirrhosis, Liver — all drugs for Cirrhosis, Liver →
• Acute Upper Gastrointestinal Hemorrhage — all drugs for Acute Upper Gastrointestinal Hemorrhage →

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Who can join

18 and older, any sex, with Cirrhosis, Liver or Acute Upper Gastrointestinal Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.