Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05809141
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-04-12
First Post:
2023-03-18
Brief Title:
Comparison Between Thromboelastography and Conventional Coagulation Tests in Pediatrics With Chronic Liver Disease
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Comparison Between Thromboelastography and Conventional Coagulation Tests in Pediatrics With Chronic Liver Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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 Wilsons 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 eg 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
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 Wilsons 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None