Acute on Top of Chronic Liver Cell FailureACLFNCT06857682
Neutrophil to Lymphocyte Ratio and Mean Platelet Volume as a Prognostic Predictor Among Patients With Acute on Top of Chronic Liver Cell Failure
An observational study of Acute on Top of Chronic Liver Cell Failure, run by Assiut University at 1 site in Egypt.
Trial summary
Acute on chronic liver failure (ACLF) is a clinical syndrome of sudden hepatic decompensation observed in patients with pre-existing chronic liver disease and associated with one or more extrahepatic organ failures and increased mortality.[1][2][3][4] Regardless of the etiology of chronic liver injury, when a… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute on Top of Chronic Liver Cell Failure
- How many people
- 170 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: above 18 years below 85 years
Who may be able to join
- Laboratory Confirmation
- Availability of complete blood count (CBC) with differentials (for NLR calculation: neutrophils/lymphocytes).
- MPV measured at baseline (preferably before interventions like transfusions or antibiotics).
- Clinical Data Availability
- Sufficient clinical and biochemical data for prognostic scoring (e.g., MELD, Child-Pugh, CLIF-SOFA).
- Follow-up data for assessing outcomes (e.g., 30-day mortality, transplant-free survival).
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- Age \& Consent
- Adults (typically ≥18 years).
- Informed consent obtained (if prospective study).
Who cannot join
- Confounding Hematologic Conditions
- Active hematologic malignancies (leukemia, lymphoma).
- Recent blood transfusions (within 48-72 hours, as they may alter NLR/MPV).
- Known myeloproliferative disorders or bone marrow suppression.
- Recent Infections or Inflammatory Conditions
- Active non-hepatic infections (e.g., sepsis, pneumonia, HIV) unless ACLF is infection-triggered.
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- Autoimmune diseases (e.g., rheumatoid arthritis, SLE) that may affect NLR.
- Medications Affecting NLR/MPV
- Recent steroid/immunosuppressant use (modifies WBC counts).
- Chemotherapy or recent surgery (alters inflammatory markers).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haematological Indices as a Prognostic Predictor Among Patients With Acute on Top of Chronic Liver Cell Failure
Acute on chronic liver failure (ACLF) is a clinical syndrome of sudden hepatic decompensation observed in patients with pre-existing chronic liver disease and associated with one or more extrahepatic organ failures and increased mortality.[1][2][3][4] Regardless of the etiology of chronic liver injury, when a clinician follows the natural history of liver injury, the initial uncomplicated chronic liver disease leads to cirrhosis and, later, the decompensation of liver function with ascites, jaundice, portal hypertension with variceal bleeding, and hepatic encephalopathy. Type-A ACLF is an acute worsening of liver function in a patient with chronic liver disease. Type-B ACLF is when this acute decompensation occurs in patients with cirrhosis, while type-C ACLF is acute worsening of liver function in decompensated cirrhotic.
The etiology of ACLF would be related to a precipitating event in the context of a pre-existing liver condition. Hepatic causes include alcohol-related injury, drug-induced liver injury, viral hepatitis (A, B, C, D, and E), hypoxic injury, or liver surgeries including trans jugular intrahepatic portosystemic shunt (TIPS) placement. Extra-hepatic causes mainly consist of bacterial infections and major surgery. An estimated 40% to 50% of patients are labeled as having an unrecognized precipitating event culminating in ACLF.[5][6][7] The precipitating event has a geographical variation, similar to the etiology of acute liver failure. While acute alcohol injury and bacterial infections are the most common precipitating factor of ACLF in the west; reactivation of chronic hepatitis B, acute hepatitis A, and E infection, along with acute alcohol injury and bacterial infections, are most common in Asia.
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- CLF can predict mortality in patient with ACLF and need consideratio for liver transplantation
- Between 24%-40% with cirrhosis develop LCF and admitted into hospital
Grading ACLF helps clinicians assess the prognosis, the usefulness of which has been validated in various studies. ACLF is stratified into 3 grades based on its severity:
Grade-1 ACLF is defined as:
- Single renal failure
- Single liver, coagulation, circulatory, or lung failure that is associated with a serum creatinine level of 1.5 to 1.9 mg/dL and/or hepatic encephalopathy grade 1 or grade 2
- A single brain failure with a serum creatinine level of 1.5 to 1.9 mg/dl Grade-2 ACLF is diagnosed when there are 2 organ failures of any combination. Grade-3 ACLF is diagnosed when there are three or more organ failures of any combination.
The neutrophil-to-lymphocyte ratio (NLR) is an easily accessible biomarker for assessing inflammatory status. It has been shown to be predictive of poor outcome in a variety of diseases, such as cardiovascular disease (8), cancer (9), and postoperative infection (10). In cirrhosis, NLR is a recognized predictor of survival in patients with hepatocarcinoma (11) or hepatitis B virus (HBV) infection, as well as in patients awaiting transplantation (12,13). Moreover, it has been shown that in uncomplicated cirrhosis, higher NLR could predict mortality independently of the model for end-stage liver disease (MELD) and Child-Pugh scores (14).
Aim of the work
- Detecting correlation between lymphocyte/neutrophil ratio and mean platelets volume (MPV)
- Short mortality rate in patients with acute in top of chronic liver cell failure
- Comparison between the predictor different prognostic score and lymphocyte/ neutrophil ratio and mean platelets volume (MPV in patients with acute in top of chronic liver cell failure
Read the detailed description
Aim of the work
- Detecting correlation between lymphocyte/neutrophil ratio and mean platelets volume (MPV)
- Short mortality rate in patients with acute in top of chronic liver cell failure
- Comparison between the predictor different prognostic score and lymphocyte/ neutrophil ratio and mean platelets volume (MPV in patients with acute in top of chronic liver cell failure
What is being measured
The primary outcome is the main question the study is designed to answer.
neutrophil / lymphocyte ratio
- Detecting correlation between neutrophil / lymphocyte ratio and mean platelets volume (MPV)
- 30 days and 90 days mortality
- Liver Transplant free survival
Measured: 12 Moths from 1/10/2024 - 1/10/2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute on Top of Chronic Liver Cell FailureStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kamel Khalaf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857682
- Sponsor's protocol ID
- liver cell failure
- Other IDs
- Assiut University
- Acronym
- ACLF
- Status last verified
- Apr 2025
- First submitted
- 27 Feb 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study is intended to be inside Assiut University and there is no other facility participate into the study
Publications
Patil V, Jain M, Venkataraman J. Paracentesis-induced acute kidney injury in decompensated cirrhosis - prevalence and predictors. Clin Exp Hepatol. 2019 Mar;5(1):55-59. doi: 10.5114/ceh.2019.83157. Epub 2019 Feb 20.
PubMed 30915407Praktiknjo M, Clees C, Pigliacelli A, Fischer S, Jansen C, Lehmann J, Pohlmann A, Lattanzi B, Krabbe VK, Strassburg CP, Arroyo V, Merli M, Meyer C, Trebicka J. Sarcopenia Is Associated With Development of Acute-on-Chronic Liver Failure in Decompensated Liver Cirrhosis Receiving Transjugular Intrahepatic Portosystemic Shunt. Clin Transl Gastroenterol. 2019 Apr;10(4):e00025. doi: 10.14309/ctg.0000000000000025.
PubMed 30939488Cai JJ, Wang K, Jiang HQ, Han T. Characteristics, Risk Factors, and Adverse Outcomes of Hyperkalemia in Acute-on-Chronic Liver Failure Patients. Biomed Res Int. 2019 Feb 27;2019:6025726. doi: 10.1155/2019/6025726. eCollection 2019.
PubMed 30937312
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haematological Indices as a Prognostic Predictor Among Patients With Acute on Top of Chronic Liver Cell Failure
- ClinicalTrials.gov ID
- NCT06857682
- Acronym / sponsor ID
- ACLF / liver cell failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 4 Mar 2025 (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.
Acute on chronic liver failure (ACLF) is a clinical syndrome of sudden hepatic decompensation observed in patients with pre-existing chronic liver disease and associated with one or more extrahepatic organ failures and increased mortality.[1][2][3][4] Regardless of the etiology of chronic liver injury, when a clinician follows the natural history of liver injury, the initial uncomplicated chronic liver disease leads to cirrhosis and, later, the decompensation of liver function with ascites, jaundice, portal hypertension with variceal bleeding, and hepatic encephalopathy. Type-A ACLF is an acute worsening of liver function in a patient with chronic liver disease. Type-B ACLF is when this acute decompensation occurs in patients with cirrhosis, while type-C ACLF is acute worsening of liver function in decompensated cirrhotic.
The etiology of ACLF would be related to a precipitating event in the context of a pre-existing liver condition. Hepatic causes include alcohol-related injury, drug-induced liver injury, viral hepatitis (A, B, C, D, and E), hypoxic injury, or liver surgeries including trans jugular intrahepatic portosystemic shunt (TIPS) placement. Extra-hepatic causes mainly consist of bacterial infections and major surgery. An estimated 40% to 50% of patients are labeled as having an unrecognized precipitating event culminating in ACLF.[5][6][7] The precipitating event has a geographical variation, similar to the etiology of acute liver failure. While acute alcohol injury and bacterial infections are the most common precipitating factor of ACLF in the west; reactivation of chronic hepatitis B, acute hepatitis A, and E infection, along with acute alcohol injury and bacterial infections, are most common in Asia.
- CLF can predict mortality in patient with ACLF and need consideratio for liver transplantation
- Between 24%-40% with cirrhosis develop LCF and admitted into hospital
Grading ACLF helps clinicians assess the prognosis, the usefulness of which has been validated in various studies. ACLF is stratified into 3 grades based on its severity:
Grade-1 ACLF is defined as:
- Single renal failure
- Single liver, coagulation, circulatory, or lung failure that is associated with a serum creatinine level of 1.5 to 1.9 mg/dL and/or hepatic encephalopathy grade 1 or grade 2
- A single brain failure with a serum creatinine level of 1.5 to 1.9 mg/dl Grade-2 ACLF is diagnosed when there are 2 organ failures of any combination. Grade-3 ACLF is diagnosed when there are three or more organ failures of any combination.
The neutrophil-to-lymphocyte ratio (NLR) is an easily accessible biomarker for assessing inflammatory status. It has been shown to be predictive of poor outcome in a variety of diseases, such as cardiovascular disease (8), cancer (9), and postoperative infection (10). In cirrhosis, NLR is a recognized predictor of survival in patients with hepatocarcinoma (11) or hepatitis B virus (HBV) infection, as well as in patients awaiting transplantation (12,13). Moreover, it has been shown that in uncomplicated cirrhosis, higher NLR could predict mortality independently of the model for end-stage liver disease (MELD) and Child-Pugh scores (14).
Aim of the work
- Detecting correlation between lymphocyte/neutrophil ratio and mean platelets volume (MPV)
- Short mortality rate in patients with acute in top of chronic liver cell failure
- Comparison between the predictor different prognostic score and lymphocyte/ neutrophil ratio and mean platelets volume (MPV in patients with acute in top of chronic liver cell failure
Detailed description
Aim of the work
- Detecting correlation between lymphocyte/neutrophil ratio and mean platelets volume (MPV)
- Short mortality rate in patients with acute in top of chronic liver cell failure
- Comparison between the predictor different prognostic score and lymphocyte/ neutrophil ratio and mean platelets volume (MPV in patients with acute in top of chronic liver cell failure
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- above 18 years below 85 years
Key inclusion criteria (9 listed)
- Laboratory Confirmation
- Clinical Data Availability
- Age \& Consent
Key exclusion criteria (10 listed)
- Confounding Hematologic Conditions
- Recent Infections or Inflammatory Conditions
- Medications Affecting NLR/MPV
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
neutrophil / lymphocyte ratio
Time frame: 12 Moths from 1/10/2024 - 1/10/2026
* Detecting correlation between neutrophil / lymphocyte ratio and mean platelets volume (MPV) * 30 days and 90 days mortality * Liver Transplant free survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Results publication: PubMed 30915407Patil V, Jain M, Venkataraman J. Paracentesis-induced acute kidney injury in decompensated cirrhosis - prevalence and predictors. Clin Exp Hepatol. 2019 Mar;5(1):55-59. doi: 10.5114/ceh.2019.83157. Epub 2019 Feb 20.
- Results publication: PubMed 30939488Praktiknjo M, Clees C, Pigliacelli A, Fischer S, Jansen C, Lehmann J, Pohlmann A, Lattanzi B, Krabbe VK, Strassburg CP, Arroyo V, Merli M, Meyer C, Trebicka J. Sarcopenia Is Associated With Development of Acute-on-Chronic Liver Failure in Decompensated Liver Cirrhosis Receiving Transjugular Intrahepatic Portosystemic Shunt. Clin Transl Gastroenterol. 2019 Apr;10(4):e00025. doi: 10.14309/ctg.0000000000000025.
- Results publication: PubMed 30937312Cai JJ, Wang K, Jiang HQ, Han T. Characteristics, Risk Factors, and Adverse Outcomes of Hyperkalemia in Acute-on-Chronic Liver Failure Patients. Biomed Res Int. 2019 Feb 27;2019:6025726. doi: 10.1155/2019/6025726. eCollection 2019.
- Individual participant dataSharing planned: No. The study is intended to be inside Assiut University and there is no other facility participate into the study
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute on Top of Chronic Liver Cell Failure, run by Assiut University at 1 site in Egypt.
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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neutrophil / lymphocyte ratio (time frame: 12 Moths from 1/10/2024 - 1/10/2026). 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 NCT06857682, which also lists 3 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 Apr 2025.