NCT05809141

Brief 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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

April 12, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

March 18, 2023

Last Update Submit

March 30, 2023

Conditions

ThromboelastographyConventional Coagulation TestsChronic Liver Disease

Outcome Measures

Primary Outcomes (3)

  • Detect the clotting time, clotting kinetics and clot stability

    By thromboelastography parameters

    Baseline

  • compare between thromboelastography and conventional coagulation tests

    in evaluation of haemostatic status in pediatrics with chronic liver disease .

    Baseline

  • Detect the advantages of thromboelastography

    predicting the risk of bleeding, assessing haemostasis and guiding blood product transfusion for each coagulation defect .

    Baseline

Interventions

thromboelastographyDIAGNOSTIC_TEST

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 .

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients aged 6m-18y with chronic liver disease

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

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

    BACKGROUND

  • 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.

    PMID: 11928081BACKGROUND

  • 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.

    PMID: 23303912BACKGROUND

  • 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.

    PMID: 35698893BACKGROUND

  • Sharma A, Nagalli S. Chronic Liver Disease. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554597/

    PMID: 32119484BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 32932542BACKGROUND

MeSH Terms

Interventions

Thrombelastography

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Mennat-Allah H Abdelraheem, MBBCh

CONTACT

+201061811080menna128hesham@yahoo.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor of pediatrics department

Study Record Dates

First Submitted

March 18, 2023

First Posted

April 12, 2023

Study Start

April 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

April 12, 2023

Record last verified: 2023-03