Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05809141
Other study ID # thromboelastography
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date March 31, 2024

Study information

Verified date March 2023
Source Assiut University
Contact Mennat-Allah H Abdelraheem, MBBCh
Phone +201061811080
Email menna128hesham@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

- Compare between thromboelastography (TEG) and conventional coagulation tests (CCT) in children with chronic liver disease who admitted to Assiut University Children Hospital. - Detect the advantages of TEG in predicting the risk of bleeding, assessing haemostasis and guiding blood product transfusion for each coagulation defect .


Description:

The liver is the largest solid organ in the body with a mass of 1200-1500 g. It develops embryologically as a glandular outgrowth of the primitive gut, forming also the largest gland of the body . The liver is the major site of synthesis of haemostatic factors and clearance of activated haemostatic factors . These factors are important to maintain dynamic balance of physiological haemostasis, including primary haemostasis (i.e. interaction between platelet [PLT] and vessel wall), coagulation cascade and fibrinolysis . Consequently, in patients with liver dysfunction, a complicated disorder of haemostatic system arises, causing both bleeding and thromboembolic complications . Chronic liver disease (CLD) is a progressive deterioration of liver functions for more than six months, which includes synthesis of clotting factors, other proteins, detoxification of harmful products of metabolism, and excretion of bile . The spectrum of etiologies is broad for chronic liver disease, which includes toxins, alcohol abuse for a prolonged time, infection, autoimmune diseases, genetic and metabolic disorders . The common causes for chronic liver disease (CLD) in children are hepatitis B, hepatitis C, hepatitis D, autoimmune hepatitis and metabolic disorders like Wilson's disease and α-1 antitrypsin deficiency . In majority of the patients the etiology remains uncertain. Signs and symptoms of CLD can be nonspecific, such as fatigue, anorexia, weight loss, or depend upon the complication that the patient has developed. The three significant complications are because of portal hypertension (esophageal varices, ascites), hepatocellular insufficiency (e.g., jaundice, hepatic encephalopathy), and hepatocellular carcinoma . Among complications of chronic liver disease: variceal bleeding, ascites, spontaneous bacterial peritonitis (SBP), hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome and hepatocellular carcinoma (HCC) . There are various scoring systems used to assess the severity of chronic liver disease . Physiological haemostasis includes primary haemostasis, coagulation cascade and fibrinolysis, which are involved with various haemostatic factors. Haemostatic tests mainly include conventional coagulation tests (CCTs) and thromboelastography (TEG) test. CCTs mainly includes PLT count, PT, APTT, and fibrinogen (FIB), d-dimer and fibrinogen degradation products (FDP) concentrations. PLT count reflects primary haemostasis by quantitative assessment of PLT. PT and APTT reflect coagulation cascade by assessment of pro-coagulants involved in the extrinsic and intrinsic pathways, respectively. FIB concentration reflects coagulation cascade by quantitative assessment of FIB. D-dimer and FDP concentrations reflect fibrinolytic activity by quantitative assessment of d-dimer and FDP . Thromboelastography (TEG), a whole blood viscoelastic test. TEG detects the clotting time, clotting kinetics and clot stability to more comprehensively evaluate haemostatic status by several parameters, mainly including reactive time (R), kinetic time (K), angle (α), maximum amplitude (MA) and lysis-30 . R reflects the activity of coagulation factors by detecting the time of fibrin formation. K and α reflect the fibrinogen function by detecting the rate of clot development. MA reflects the platelet function by detecting the maximum clot strength. Lysis 30 reflects fibrinolytic activity by detecting the degree of fibrinolysis .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 33
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers
Gender All
Age group 6 Months to 18 Years
Eligibility Inclusion Criteria: - Patients with chronic liver disease of any aetiology as (congenital hepatic fibrosis, liver cirrhosis, autoimmune hepatitis, Wilson disease, metabolic liver disease and others ). - Patients aged 6m- 18y . Exclusion Criteria: - Patients who received transfusion of blood products within 48hr prior to sample collection. - Patients who are on therapy with antiplatelet drugs or anticoagulants. - Patients with history of primary disease with coagulation disturbance (paroxysmal nocturnal hemoglobinuria, polycythemia, idiopathic thrombocytopenia, haemophilia. - Patients with concomitant chronic kidney disease.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
thromboelastography
Thromboelastography (TEG), a whole blood viscoelastic test. TEG detects the clotting time, clotting kinetics and clot stability to more comprehensively evaluate haemostatic status by several parameters, mainly including reactive time (R), kinetic time (K), angle (a), maximum amplitude (MA) and lysis-30 .

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (8)

Amitrano L, Guardascione MA, Brancaccio V, Balzano A. Coagulation disorders in liver disease. Semin Liver Dis. 2002 Feb;22(1):83-96. doi: 10.1055/s-2002-23205. — View Citation

Chronic hepatitis and autoimmune chronic active hepatitis. In: Alex P.Movat (eds). Liver disorders in childhood 3rd edition. Oxford, Butterworth- Heinemann Ltd, 1994, pp. 180-96.

He Y, Yao H, Ageno W, Mendez-Sanchez N, Guo X, Qi X. Review article: thromboelastography in liver diseases. Aliment Pharmacol Ther. 2022 Aug;56(4):580-591. doi: 10.1111/apt.17080. Epub 2022 Jun 14. — View Citation

Janko N, Majeed A, Kemp W, Roberts SK. Viscoelastic Tests as Point-of-Care Tests in the Assessment and Management of Bleeding and Thrombosis in Liver Disease. Semin Thromb Hemost. 2020 Sep;46(6):704-715. doi: 10.1055/s-0040-1715475. Epub 2020 Sep 15. — View Citation

Sharma A, Nagalli S. Chronic liver disease. InStatPearls [Internet] 2021 Nov 25. StatPearls Publishing.

Versteeg HH, Heemskerk JW, Levi M, Reitsma PH. New fundamentals in hemostasis. Physiol Rev. 2013 Jan;93(1):327-58. doi: 10.1152/physrev.00016.2011. — View Citation

Viral hepatitis/Chronic hepatitis/Portal hypertension. In: Sherlock S, Dooley J, (eds). Diseases of liver and biliary system 10th edition. Oxford, Blackwell Science Ltd, 1997, pp. 162-3, 265-333.

Yang LL. Anatomy and Physiology of the Liver. Anesthesia for Hepatico-Pancreatic-Biliary Surgery and Transplantation. 2021:15-40.

Outcome

Type Measure Description Time frame Safety issue
Primary Detect the clotting time, clotting kinetics and clot stability By thromboelastography parameters Baseline
Primary compare between thromboelastography and conventional coagulation tests in evaluation of haemostatic status in pediatrics with chronic liver disease . Baseline
Primary Detect the advantages of thromboelastography predicting the risk of bleeding, assessing haemostasis and guiding blood product transfusion for each coagulation defect . Baseline
See also
  Status Clinical Trial Phase
Completed NCT03704792 - Validation of the Second Generation of the Controlled Attenuation Parameter (CAP) Using the MRI-PDFF as Reference N/A
Terminated NCT02949375 - Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease Phase 2
Active, not recruiting NCT01205074 - ¹³C-Methacetin Breath Test (MBT) Methodology Study Phase 2/Phase 3
Completed NCT00756171 - Colesevelam Versus Placebo in Cholestatic Pruritus Phase 2/Phase 3
Completed NCT01195181 - Different PEG-interferon and Ribavirin Schedules for Chronic Hepatitis C in the Real Clinical Practice. Phase 4
Completed NCT05044663 - Liver and Splenic Stiffness in Predicting Esophageal Varices Needing Treatment in NASH Related Compensated Advanced Chronic Liver Disease.
Recruiting NCT04588077 - Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis Phase 4
Recruiting NCT04802954 - Risk Stratification of Hepatocarcinogenesis Using a Deep Learning Based Clinical, Biological and Ultrasound Model in High-risk Patients N/A
Recruiting NCT04622449 - Etiopathogenesis of Anemia in Chronic Liver Disease
Enrolling by invitation NCT05836246 - The Development of Quantitative Ultrasound Imaging Software Platform
Completed NCT03087344 - Postprandial Liver and Spleen Stiffness Measurements in the Noninvasive Diagnosis of Cirrhosis N/A
Completed NCT04751045 - Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies N/A
Not yet recruiting NCT04526548 - A Diagnostic Study on Patients With Drug-induced Liver Injury
Withdrawn NCT02899325 - FDGal PET/CT to Detect Hepatocellular Carcinoma
Suspended NCT02650011 - Clinical Features and Natural History of Acute-on-Chronic Liver Failure in Korean Patients With Chronic Liver Disease
Terminated NCT02530567 - Non-invasive Evaluation of Portal Pressure by MRI N/A
Completed NCT01851252 - MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy Phase 1
Terminated NCT01756690 - Predicting Lung Injury From Transfusion in Patients With Liver Disease N/A
Completed NCT01600105 - Detection of Liver Fibrosis With Magnetic Resonance Imaging (MRI) Phase 4
Completed NCT01008293 - Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life Phase 2/Phase 3