ThromboelastographyNCT05809141
Comparison Between Thromboelastography and Conventional Coagulation Tests in Pediatrics With Chronic Liver Disease
An observational study of Thromboelastography and Conventional Coagulation Tests, run by Assiut University.
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… Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Thromboelastography, Conventional Coagulation Tests, Chronic Liver Disease
- What is being tested?
- thromboelastography
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 31 Mar 2024
- 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 6 months to 18 years
- All sexes
- Child, Adult
Study population: patients aged 6m-18y with chronic liver disease
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
- 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 .
Read the detailed 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 .
- Being tested
- thromboelastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 .
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect the clotting time, clotting kinetics and clot stability
By thromboelastography parameters
Measured: Baseline
compare between thromboelastography and conventional coagulation tests
in evaluation of haemostatic status in pediatrics with chronic liver disease .
Measured: Baseline
Detect the advantages of thromboelastography
predicting the risk of bleeding, assessing haemostasis and guiding blood product transfusion for each coagulation defect .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ThromboelastographyStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mennat-Allah Hesham Abdelraheem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809141
- Sponsor's protocol ID
- thromboelastography
- Status last verified
- Mar 2023
- First submitted
- 18 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang LL. Anatomy and Physiology of the Liver. Anesthesia for Hepatico-Pancreatic-Biliary Surgery and Transplantation. 2021:15-40.
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.
PubMed 11928081Versteeg 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.
PubMed 23303912He 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.
PubMed 35698893Sharma A, Nagalli S. Chronic Liver Disease. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554597/
PubMed 32119484Chronic 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.
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.
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.
PubMed 32932542
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Thromboelastography and Conventional Coagulation Tests in Pediatrics With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT05809141
- Acronym / sponsor ID
- thromboelastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 12 Apr 2023 (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.
- 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 .
Detailed 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 .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- patients aged 6m-18y with chronic liver disease
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thromboelastographyThromboelastography (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 . | Diagnostic test | – |
Primary outcome
Detect the clotting time, clotting kinetics and clot stability
Time frame: Baseline
By thromboelastography parameters
compare between thromboelastography and conventional coagulation tests
Time frame: Baseline
in evaluation of haemostatic status in pediatrics with chronic liver disease .
Detect the advantages of thromboelastography
Time frame: Baseline
predicting the risk of bleeding, assessing haemostasis and guiding blood product transfusion for each coagulation defect .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- BackgroundYang LL. Anatomy and Physiology of the Liver. Anesthesia for Hepatico-Pancreatic-Biliary Surgery and Transplantation. 2021:15-40.
- Background: PubMed 11928081Amitrano 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.
- Background: PubMed 23303912Versteeg 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.
- Background: PubMed 35698893He 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.
- Background: PubMed 32119484Sharma A, Nagalli S. Chronic Liver Disease. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554597/
- BackgroundChronic 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.
- BackgroundViral 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: PubMed 32932542Janko 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.
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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 Thromboelastography and Conventional Coagulation Tests, 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 2 inclusion and 4 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 12 Apr 2023. 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 Mennat-Allah H Abdelraheem, MBBCh (+201061811080, menna128hesham@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect the clotting time, clotting kinetics and clot stability (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT05809141, which also lists 8 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 12 Apr 2023.