Etiopathogenesis of Anemia in Chronic Liver Disease

NCT04622449 | Unknown

• 1 other identifier: IM/2020/1624
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Anemia is the most common complication of liver cirrhosis and is seen in 75% of cases. The etiology of anemia in liver disease is diverse and often multi-factorial. Given the diverse and sometimes multifactorial etiology of cirrhosis, it is difficult to determine the exact cause of anemia in these groups of patients. The most common type of anemia encountered in liver cirrhosis is normocytic normochromic anemia, attributable to the chronic inflammatory state. The key question in management of anemia in patients with liver disease which specific factor needs to be corrected to restore hemoglobin levels and improve overall clinical status and improve severity scores.

Conditions

Anemia; Chronic Liver Disease

Keywords

Gastro Intestinal Bleeding; Iron Deficiency Anemia; Cirrhosis; Anemia of Chronic disease; Nutritional deficiency

Outcome Measures

Primary Outcomes (2)

• Etiologies of anemia in patients with liver disease

  Determine the prevalence of various etiologies of anemia in patients with liver disease

  1 month

• Correlation with liver disease severity

  Association of liver disease severity as measured by MELD, MELD Na and CTP scores with severity of anemia

  1 month

Study Arms (1)

Chronic liver disease with anemia

All patients with anemia as diagnosed by WHO criteria in patients with liver disease of any etiology.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with chronic liver disease attending outpatient department of hepatology, admitted under hepatology department or emergency services

You may qualify if:

• Age 18-75 years
• Either gender
• Patients with chronic liver disease with anemia (Hemoglobin in Non-pregnant women (18 years of age and above) \<12g/dl and in men \<13g/dl

You may not qualify if:

• Those who do not consent to participate in the study
• Renal dysfunction (S. Creatinine ≥ 2mg/dL)
• Pregnancy/Lactation
• Post liver transplant patients
• HIV infection
• Patients who are on psychoactive drugs, like sedatives or antidepressants
• Patients with uncontrolled sepsis
• Patients who are too sick to carry out the protocol
• Patients with ongoing active bleeding
• Patients with known primary hematological disorders

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

PGIMER

Chandigarh, 160012, India

RECRUITING

Related Publications (14)

• Gonzalez-Casas R, Jones EA, Moreno-Otero R. Spectrum of anemia associated with chronic liver disease. World J Gastroenterol. 2009 Oct 7;15(37):4653-8. doi: 10.3748/wjg.15.4653.

  PMID: 19787828 BACKGROUND

• Premkumar M, Saxena P, Rangegowda D, Baweja S, Mirza R, Jain P, Bhatia P, Kumar G, Bihari C, Kalal C, Vyas T, Choudhury A, Sarin SK. Coagulation failure is associated with bleeding events and clinical outcome during systemic inflammatory response and sepsis in acute-on-chronic liver failure: An observational cohort study. Liver Int. 2019 Apr;39(4):694-704. doi: 10.1111/liv.14034. Epub 2019 Feb 7.

  PMID: 30589495 BACKGROUND

• Nahon P, Nuraldeen R, Rufat P, Sutton A, Trautwein C, Strnad P. In alcoholic cirrhosis, low-serum hepcidin levels associate with poor long-term survival. Liver Int. 2016 Feb;36(2):185-8. doi: 10.1111/liv.13007. Epub 2015 Dec 6.

  PMID: 26561367 BACKGROUND

• Mathurin SA, Aguero AP, Dascani NA, Prestera JA, Gianserra C, Londero E, Chiorra C. [Anemia in hospitalized patients with cirrhosis: prevalence, clinical relevance and predictive factors]. Acta Gastroenterol Latinoam. 2009 Jun;39(2):103-11. Spanish.

  PMID: 19663083 BACKGROUND

• Stein J, Connor S, Virgin G, Ong DE, Pereyra L. Anemia and iron deficiency in gastrointestinal and liver conditions. World J Gastroenterol. 2016 Sep 21;22(35):7908-25. doi: 10.3748/wjg.v22.i35.7908.

  PMID: 27672287 BACKGROUND

• Tan TC, Crawford DH, Franklin ME, Jaskowski LA, Macdonald GA, Jonsson JR, Watson MJ, Taylor PJ, Fletcher LM. The serum hepcidin:ferritin ratio is a potential biomarker for cirrhosis. Liver Int. 2012 Oct;32(9):1391-9. doi: 10.1111/j.1478-3231.2012.02828.x. Epub 2012 Jun 7.

  PMID: 22676252 BACKGROUND

• Gkamprela E, Deutsch M, Pectasides D. Iron deficiency anemia in chronic liver disease: etiopathogenesis, diagnosis and treatment. Ann Gastroenterol. 2017;30(4):405-413. doi: 10.20524/aog.2017.0152. Epub 2017 May 3.

  PMID: 28655976 BACKGROUND

• Alexopoulou A, Vasilieva L, Kanellopoulou T, Pouriki S, Soultati A, Dourakis SP. Presence of spur cells as a highly predictive factor of mortality in patients with cirrhosis. J Gastroenterol Hepatol. 2014 Apr;29(4):830-4. doi: 10.1111/jgh.12473.

  PMID: 24325340 BACKGROUND

• Paternostro R, Kapzan L, Mandorfer M, Schwarzer R, Benedikt S, Viveiros A, Bauer D, Ferlitsch M, Zoller H, Trauner M, Ferlitsch A. Anemia and iron deficiency in compensated and decompensated cirrhosis: Prevalence and impact on clinical outcomes. J Gastroenterol Hepatol. 2020 Sep;35(9):1619-1627. doi: 10.1111/jgh.14988. Epub 2020 Feb 26.

  PMID: 31972057 BACKGROUND

• Intragumtornchai T, Rojnukkarin P, Swasdikul D, Israsena S. The role of serum ferritin in the diagnosis of iron deficiency anaemia in patients with liver cirrhosis. J Intern Med. 1998 Mar;243(3):233-41. doi: 10.1046/j.1365-2796.1998.00290.x.

  PMID: 9627161 BACKGROUND

• Vassiliadis T, Mpoumponaris A, Vakalopoulou S, Giouleme O, Gkissakis D, Grammatikos N, Soufleris K, Kakafika A, Tziomalos K, Patsiaoura K, Papanikolaou V, Evgenidis N. Spur cells and spur cell anemia in hospitalized patients with advanced liver disease: Incidence and correlation with disease severity and survival. Hepatol Res. 2010 Feb;40(2):161-70. doi: 10.1111/j.1872-034X.2009.00590.x. Epub 2010 Jan 11.

  PMID: 20070401 BACKGROUND

• Liangpunsakul S, Ulmer BJ, Chalasani N. Predictors and implications of severe hypersplenism in patients with cirrhosis. Am J Med Sci. 2003 Sep;326(3):111-6. doi: 10.1097/00000441-200309000-00001.

  PMID: 14501224 BACKGROUND

• Simbrunner B, Beer A, Woran K, Schmitz F, Primas C, Wewalka M, Pinter M, Dolak W, Scheiner B, Puespoek A, Trauner M, Oberhuber G, Mandorfer M, Reiberger T. Portal hypertensive gastropathy is associated with iron deficiency anemia. Wien Klin Wochenschr. 2020 Jan;132(1-2):1-11. doi: 10.1007/s00508-019-01593-w. Epub 2020 Jan 7.

  PMID: 31912289 BACKGROUND

• Bothou C, Ruschenbaum S, Kubesch A, Quenstedt L, Schwarzkopf K, Welsch C, Zeuzem S, Welzel TM, Lange CM. Anemia and Systemic Inflammation Rather than Arterial Circulatory Dysfunction Predict Decompensation of Liver Cirrhosis. J Clin Med. 2020 Apr 26;9(5):1263. doi: 10.3390/jcm9051263.

  PMID: 32357568 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Frozen Serum Samples to measure IL-1, IL-6, Hepcidin levels

MeSH Terms

Conditions

Anemia; Gastrointestinal Hemorrhage; Anemia, Iron-Deficiency; Fibrosis; Malnutrition

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders

Study Officials

• Madhumita Premkumar, MD, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madhumita Premkumar, MD, DM

CONTACT

+9101722756344; drmadhumitap1@gmail.com

Arnav Aggarwal, MD

CONTACT

+918527459774; arnav272@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Hepatology

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 10, 2020
• Study Start: September 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 31, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)