Objective Scores in Variceal Bleeding

Variceal Hemorrhage Clinical Trial

Official title:

Accuracy of Simple Objective Scores in Prediction of Short-Term Outcome Among Cirrhotic Patients With Variceal Bleeding

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06325436
• Other study ID #: scores in variceal bleeding
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Rawnaa Hosny Ammar, Resident
• Phone: +201090155390
• Email: rawnaahosny[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the prognostic performance of the ALBI associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores.

Description:

Acute variceal bleeding is the most common feature of decompensation in patients with cirrhosis and one of the life-threatening complications, causing significant morbidity and mortality in patients with cirrhosis 2,3.

Although much progress has been made in diagnosis and treatment the 6-week mortality rate remains high, ranging from 10 to 20%, mainly due to failure to control bleeding in the first days 4-5.

It is therefore critical to develop a prognostic method for patients with acute variceal bleeding to determine the risk of re-bleeding 6 and resistance to standard treatment (accounting for 20-30%) 7 and death to adopt more aggressive treatment measures.

Many existing scoring systems have been used to evaluate the prognosis of patients with variceal bleeding, but none of them are targeted: including the Child-Pugh score, Model for End-Stage Liver Disease (MELD), and MELD-Na, clinical Rockall score (CRS), AIMS65 score (AIMS65), and Glasgow-Blatchford score (GBS) 9-11 However, these scores have the limitation that some information is subjective, and they use several tests that are less specific for liver disease, meaning that the best method to stratify risk of re-bleeding and morality among cirrhotic patients is still not clear.

In recent years, some new scores have been introduced. One of these scoring systems is the serum albumin and total bilirubin (ALBI) score that was developed to assess outcome in patients with hepatocellular carcinoma (HCC) and primary biliary cholangitis.

ALBI grade is a simple score derived from an easily accessible without using those factors evaluated subjectively (such as ascites and encephalopathy)14 and some studies suggest that it may provide better/similar prognostic performance compared with other well established prognostic scores like CTP score, MELD score 15.

The platelet-albumin-bilirubin (PALBI) score16 was initially used for the assessment of patients with HCC undergoing resection or ablation and later has been used as a predictor of mortality in patients with cirrhosis related complications 17.

PALBI score on admission is a good prognostic indicator for patients with acute variceal bleeding and predicts early mortality and rebleeding. The PALBI score performed better in predicting short-term outcome and the incidence of rebleeding compared with the other 4 scoring systems for acute variceal bleeding 18 .

Another simple score, the international normalized ratio-albumin-bilirubin (INR-ALBL) score, to predict rebleeding in patients with esopho-gastric variceal bleeding following endoscopic therapy for liver cirrhosis19.

The INR-ALB grading system successfully assessed rebleeding, particularly early rebleeding, in cirrhotic patients with EGVB following endoscopic therapy. 20.

These ALBI -associated scores have received a lot of attention and are considered potential alternatives to CTP and MELD as prognostic indicators in patients with liver cirrhosis. These objective scores are considered better predictors of liver decompensated events, especially in stratifying risk for portal hypertension 14,21 MELD 3.0 affords more accurate mortality prediction in general than MELD Na and addresses determinants of waitlist outcomes including the sex disparity 22.

A MELD 3.0 less than 12 was associated with less than 5 % mortality and >20 was associated with >20% mortality 23.

Secondary to drawbacks of CTP (evaluated subjectively) and MELD (complexity in its calculation) for prognosis of patients with variceal bleeding, ALBI -associated scores (ALBI, PALBI and INR-ALBI) could be rapid, effective, and validated scores in prediction the outcome of such patients and to identify candidates for an early transjugular intrahepatic porto-systemic shunt procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 85
• Est. completion date: January 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any cirrhotic patients above the age of 18 years old of both sexes, present with variceal bleeding.

Exclusion Criteria:

• Patients with other causes of upper gastrointestinal bleeding (UGIB).

• Patients who are receiving anticoagulant or antiplatelet therapy.

• Patients with HCC, other malignant tumors, and hematological disease at the time of recruitment or during follow up.

• Patients who underwent transjugular intrahepatic portosystemic shunt, splenectomy, or partial splenic embolization.

• Patients with liver cirrhosis and portal vein thrombosis.

Related Conditions & MeSH terms

• Hemorrhage
• Variceal Hemorrhage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (18)

Alqahtani SA, Jang S. Pathophysiology and Management of Variceal Bleeding. Drugs. 2021 Apr;81(6):647-667. doi: 10.1007/s40265-021-01493-2. Epub 2021 Mar 12. — View Citation

Boregowda U, Umapathy C, Halim N, Desai M, Nanjappa A, Arekapudi S, Theethira T, Wong H, Roytman M, Saligram S. Update on the management of gastrointestinal varices. World J Gastrointest Pharmacol Ther. 2019 Jan 21;10(1):1-21. doi: 10.4292/wjgpt.v10.i1.1. — View Citation

Buckholz A, Wong R, Curry MP, Baffy G, Chak E, Rustagi T, Mohanty A, Fortune BE. MELD, MELD 3.0, versus Child score to predict mortality after acute variceal hemorrhage: A multicenter US cohort. Hepatol Commun. 2023 Sep 11;7(10):e0258. doi: 10.1097/HC9.0000000000000258. eCollection 2023 Oct 1. — View Citation

Chan AW, Chan RC, Wong GL, Wong VW, Choi PC, Chan HL, To KF. New simple prognostic score for primary biliary cirrhosis: Albumin-bilirubin score. J Gastroenterol Hepatol. 2015 Sep;30(9):1391-6. doi: 10.1111/jgh.12938. — View Citation

de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available. — View Citation

Drolz A, Ferlitsch A, Fuhrmann V. Management of Coagulopathy during Bleeding and Invasive Procedures in Patients with Liver Failure. Visc Med. 2018 Aug;34(4):254-258. doi: 10.1159/000491106. Epub 2018 Jul 16. — View Citation

Elshaarawy O, Allam N, Abdelsameea E, Gomaa A, Waked I. Platelet-albumin-bilirubin score - a predictor of outcome of acute variceal bleeding in patients with cirrhosis. World J Hepatol. 2020 Mar 27;12(3):99-107. doi: 10.4254/wjh.v12.i3.99. — View Citation

Jairath V, Rehal S, Logan R, Kahan B, Hearnshaw S, Stanworth S, Travis S, Murphy M, Palmer K, Burroughs A. Acute variceal haemorrhage in the United Kingdom: patient characteristics, management and outcomes in a nationwide audit. Dig Liver Dis. 2014 May;46(5):419-26. doi: 10.1016/j.dld.2013.12.010. Epub 2014 Jan 14. — View Citation

Johnson PJ, Berhane S, Kagebayashi C, Satomura S, Teng M, Reeves HL, O'Beirne J, Fox R, Skowronska A, Palmer D, Yeo W, Mo F, Lai P, Inarrairaegui M, Chan SL, Sangro B, Miksad R, Tada T, Kumada T, Toyoda H. Assessment of liver function in patients with hepatocellular carcinoma: a new evidence-based approach-the ALBI grade. J Clin Oncol. 2015 Feb 20;33(6):550-8. doi: 10.1200/JCO.2014.57.9151. Epub 2014 Dec 15. — View Citation

Kim WR, Mannalithara A, Heimbach JK, Kamath PS, Asrani SK, Biggins SW, Wood NL, Gentry SE, Kwong AJ. MELD 3.0: The Model for End-Stage Liver Disease Updated for the Modern Era. Gastroenterology. 2021 Dec;161(6):1887-1895.e4. doi: 10.1053/j.gastro.2021.08.050. Epub 2021 Sep 3. — View Citation

Li F, Wang T, Liang J, Qian B, Tang F, Gao Y, Lv J. Albumin-bilirubin grade and INR for the prediction of esophagogastric variceal rebleeding after endoscopic treatment in cirrhosis. Exp Ther Med. 2023 Sep 11;26(5):501. doi: 10.3892/etm.2023.12200. eCollection 2023 Nov. — View Citation

Reiberger T, Puspok A, Schoder M, Baumann-Durchschein F, Bucsics T, Datz C, Dolak W, Ferlitsch A, Finkenstedt A, Graziadei I, Hametner S, Karnel F, Krones E, Maieron A, Mandorfer M, Peck-Radosavljevic M, Rainer F, Schwabl P, Stadlbauer V, Stauber R, Tilg H, Trauner M, Zoller H, Schofl R, Fickert P. Austrian consensus guidelines on the management and treatment of portal hypertension (Billroth III). Wien Klin Wochenschr. 2017 Nov;129(Suppl 3):135-158. doi: 10.1007/s00508-017-1262-3. Epub 2017 Oct 23. — View Citation

Sharara AI, Rockey DC. Gastroesophageal variceal hemorrhage. N Engl J Med. 2001 Aug 30;345(9):669-81. doi: 10.1056/NEJMra003007. No abstract available. — View Citation

Shetty K, Rybicki L, Carey WD. The Child-Pugh classification as a prognostic indicator for survival in primary sclerosing cholangitis. Hepatology. 1997 May;25(5):1049-53. doi: 10.1002/hep.510250501. — View Citation

van Dam GM, Gips CH, Reisman Y, Maas KW, Purmer IM, Huizenga JR, Verbaan BW. Major clinical events, signs and severity assessment scores related to actual survival in patients who died from primary biliary cirrhosis. A long-term historical cohort study. Hepatogastroenterology. 1999 Jan-Feb;46(25):108-15. — View Citation

Wang J, Zhang Z, Yan X, Li M, Xia J, Liu Y, Chen Y, Jia B, Zhu L, Zhu C, Huang R, Wu C. Albumin-Bilirubin (ALBI) as an accurate and simple prognostic score for chronic hepatitis B-related liver cirrhosis. Dig Liver Dis. 2019 Aug;51(8):1172-1178. doi: 10.1016/j.dld.2019.01.011. Epub 2019 Jan 26. — View Citation

Yang H, Pan C, Liu Q, Wang Y, Liu Z, Cao X, Lei J. Correlation between the Glasgow-Blatchford score, shock index, and Forrest classification in patients with peptic ulcer bleeding. Turk J Med Sci. 2020 Jun 23;50(4):706-712. doi: 10.3906/sag-1906-154. — View Citation

Zhao Y, Ren M, Lu G, Lu X, Yin Y, Zhang D, Wang X, Ma W, Li Y, Cai G, Lin Y, He S. The Prognosis Analysis of Liver Cirrhosis with Acute Variceal Bleeding and Validation of Current Prognostic Models: A Large Scale Retrospective Cohort Study. Biomed Res Int. 2020 Aug 16;2020:7372868. doi: 10.1155/2020/7372868. eCollection 2020. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the prognostic performance of the ALBI_associated scores and new MELD .3 in predicting the short-term outcomes of patients with cirrhosis presenting with acute variceal bleeding.	assess the prognostic performance of the ALBI_associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores.	baseline