Variceal HemorrhageNCT06325436
Objective Scores in Variceal Bleeding
An observational study of Variceal Hemorrhage, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Variceal Hemorrhage
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to 1 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any cirrhotic patients present with variceal bleeding.
Who may be able to join
- Any cirrhotic patients above the age of 18 years old of both sexes, present with variceal bleeding.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Accuracy of Simple Objective Scores in Prediction of Short-Term Outcome Among Cirrhotic Patients With Variceal Bleeding
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.
Read the detailed 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.
- Conditions
- Variceal Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study startMar 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Variceal HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawnaa Hosny Ammar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325436
- Sponsor's protocol ID
- scores in variceal bleeding
- Status last verified
- Mar 2024
- First submitted
- 16 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33710585Drolz 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.
PubMed 30345282Reiberger 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.
PubMed 29063233de 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.
PubMed 26047908Sharara AI, Rockey DC. Gastroesophageal variceal hemorrhage. N Engl J Med. 2001 Aug 30;345(9):669-81. doi: 10.1056/NEJMra003007. No abstract available.
PubMed 11547722Johnson 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.
PubMed 25512453Chan 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.
PubMed 25753927Elshaarawy 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.
PubMed 32231763Li 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.
PubMed 37822588Wang 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.
PubMed 30765220Kim 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.
PubMed 34481845Buckholz 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.
PubMed 37695092Jairath 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.
PubMed 24433997Boregowda 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.
PubMed 30697445Yang 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.
PubMed 32041384
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Simple Objective Scores in Prediction of Short-Term Outcome Among Cirrhotic Patients With Variceal Bleeding
- ClinicalTrials.gov ID
- NCT06325436
- Acronym / sponsor ID
- scores in variceal bleeding
- Conditions
- Variceal Hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any cirrhotic patients present with variceal bleeding.
Key inclusion criteria (1 listed)
- Any cirrhotic patients above the age of 18 years old of both sexes, present with variceal bleeding.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Background: PubMed 33710585Alqahtani 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.
- Background: PubMed 30345282Drolz 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.
- Background: PubMed 29063233Reiberger 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.
- Background: PubMed 26047908de 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.
- Background: PubMed 11547722Sharara AI, Rockey DC. Gastroesophageal variceal hemorrhage. N Engl J Med. 2001 Aug 30;345(9):669-81. doi: 10.1056/NEJMra003007. No abstract available.
- Background: PubMed 25512453Johnson 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.
- Background: PubMed 25753927Chan 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.
- Background: PubMed 32231763Elshaarawy 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.
- Background: PubMed 37822588Li 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.
- Background: PubMed 30765220Wang 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.
- Background: PubMed 34481845Kim 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.
- Background: PubMed 37695092Buckholz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Variceal Hemorrhage, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rawnaa Hosny Ammar, Resident (+201090155390, rawnaahosny@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06325436, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.