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patient with liver cirrhosis was supposed to have autoanticoagulation which approved to be wrong, with absence of conventional method to detect all abnormalities in coagulation state. Thromboelastography (TEG) give a broad picture for the coagulation defects.
In addition to that no guidelines prescribed anticoagulants for venous thromboembolism in cirrhotic, so the investigators will do a study to demonstrate frequency and risk factors for acute venous thromboembolism in cirrhotic patients, find a conventional laboratory method and test TEG to assess risk of thrombosis in cirrhotic patients.Also, to validate current algorithm for use of anticoagulant and antiplatelet for thromboembolism for non cirrhotic in cirrhotic patients.
Nowadays, the term "autoanticoagulated" ,which prescribed coagulopathy state in chronic liver disease (CLD) patients due to impaired synthesis of coagulation factors and elevated international normalized ratio(INR), has been approved to be wrong and those patients are liable for venous thromboembolism (VTE) with 0.5% - 6.3% incidence of deep venous thrombosis (DVT) and pulmonary thromboembolism (PE) among cirrhotic patients.
This may be explained by normal or even increased production of factor VIII and von Willebrand factor, enhanced thrombin activity and Low level of protein C, protein S and antithrombin III due to impaired liver synthesis, other risk factor include sedentary lifestyle, fractures, immobility, hospitalization, elevated estrogen levels, surgery, concomitant disease states and cancer, damaged vasculature that increases inflammation, and sluggish splanchnic blood flow, which are all common in those patients.
Absence of gold standard estimation for hypercoagulability in cirrhotic patients, is a big problem. During measurement of conventional parameters such as international normalized ratio (INR) or partial thromboplastin time, reagents used to measure the prothrombin time do not contain thrombomodulin on which protein C depend for activation, so it does not adequately reflect reduced levels protein C. Thromboelastography a device that has the ability to measure whole blood coagulation cascade including platelet function, It can be used to monitor coagulation status before liver transplantation operation to properly identify and treat coagulation abnormalities.
No worldwide guidelines is established neither for management nor prophylaxis of VTE in cirrhotic patients, this may be due to safety concerns regarding the risk of bleeding related to anticoagulant drugs when used in people with advanced liver disease, especially if there is significant thrombocytopenia, and/or the presence of varices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirrhotic with venous thromboembolism | cirrhotic patients with a venous thromboembolic event (including deep venous thrombosis, pulmonary embolism, acute non-malignant portal vein thrombosis, splenic vein, inferior vena cava thrombosis or mesenteric vascular occlusion). Each patient will subjected to through history taking and careful examination to detect and risk factors also laboratory work to detect thrombocytopenia, disease severity, coagulation status thrombelastography before starting anticoagulants.
|
| |
| Cirrhotic without venous thromboembolism | cirrhotic patients without any thrombotic events Each patient will subjected to through history taking and careful examination to detect and risk factors. - Protein C, protein S and antithrombin III level will be assessed at baseline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thromboelastography | Device | thromboelastography will assess all coagulation abnormalities including platelets function in cirrhotic group with venous thromboembolism , and guide us about is there increased thrombosis risk or not, for that a fresh blood sample will be withdrawn from each patient before starting any treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of recanalization of thrombosed vessel | Efficacy of anticoagulants describe its ability to prevent further thrombosis and restore patency of thrmobosed vessel | 24 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| detect safety of anticoagulants in cirrhotic | Occurrence of any bleeding event while on anticoagulants therapy | During treatment period wither 12 or 24 weeks from starting therapy |
| Correlate thromboelastography results with hypercoagluable state in cirrhotic patients with venous thromboembolism |
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Inclusion Criteria:
Exclusion Criteria:
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liver cirrhosis patients with acute venous thromboembolism (VTE), control group of cirrhotic patients without VTE
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Radwan Riad | Contact | +2 01126435001 | dr.radwan1988@gmail.com | |
| Mohamed Abdel Sabour Mohamed Mekky | Contact | mmekky75@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Mohamed Abdel Sabour Mohamed Mekky | Assiut University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university | Asyut | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18443906 | Background | Gulley D, Teal E, Suvannasankha A, Chalasani N, Liangpunsakul S. Deep vein thrombosis and pulmonary embolism in cirrhosis patients. Dig Dis Sci. 2008 Nov;53(11):3012-7. doi: 10.1007/s10620-008-0265-3. Epub 2008 Apr 29. | |
| 16863556 | Background | Northup PG, McMahon MM, Ruhl AP, Altschuler SE, Volk-Bednarz A, Caldwell SH, Berg CL. Coagulopathy does not fully protect hospitalized cirrhosis patients from peripheral venous thromboembolism. Am J Gastroenterol. 2006 Jul;101(7):1524-8; quiz 1680. doi: 10.1111/j.1572-0241.2006.00588.x. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D013916 | Thrombelastography |
| ID | Term |
|---|---|
| D001780 | Blood Coagulation Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
Changes in r, k and MA- TEG parameters in cirrhotic patients with venous thromboembolism |
| 1 day |
| 28088580 | Background | Dhar A, Mullish BH, Thursz MR. Anticoagulation in chronic liver disease. J Hepatol. 2017 Jun;66(6):1313-1326. doi: 10.1016/j.jhep.2017.01.006. Epub 2017 Jan 12. |
| 19706293 | Background | Tripodi A, Primignani M, Chantarangkul V, Dell'Era A, Clerici M, de Franchis R, Colombo M, Mannucci PM. An imbalance of pro- vs anti-coagulation factors in plasma from patients with cirrhosis. Gastroenterology. 2009 Dec;137(6):2105-11. doi: 10.1053/j.gastro.2009.08.045. Epub 2009 Aug 23. |
| 23583273 | Background | Tripodi A, Primignani M, Lemma L, Chantarangkul V, Mannucci PM. Evidence that low protein C contributes to the procoagulant imbalance in cirrhosis. J Hepatol. 2013 Aug;59(2):265-70. doi: 10.1016/j.jhep.2013.03.036. Epub 2013 Apr 11. |
| 16871542 | Background | Tripodi A, Primignani M, Chantarangkul V, Clerici M, Dell'Era A, Fabris F, Salerno F, Mannucci PM. Thrombin generation in patients with cirrhosis: the role of platelets. Hepatology. 2006 Aug;44(2):440-5. doi: 10.1002/hep.21266. |
| 15726661 | Background | Tripodi A, Salerno F, Chantarangkul V, Clerici M, Cazzaniga M, Primignani M, Mannuccio Mannucci P. Evidence of normal thrombin generation in cirrhosis despite abnormal conventional coagulation tests. Hepatology. 2005 Mar;41(3):553-8. doi: 10.1002/hep.20569. |
| 3016943 | Background | van Wijngaarden A, van den Besselaar AM, Bertina RM. Thrombomodulin activity in commercial thromboplastin preparations. Thromb Res. 1986 Aug 1;43(3):265-74. doi: 10.1016/0049-3848(86)90146-5. |
| 27470055 | Background | Tripodi A, Primignani M, Braham S, Chantarangkul V, Clerici M, Moia M, Peyvandi F. Coagulation parameters in patients with cirrhosis and portal vein thrombosis treated sequentially with low molecular weight heparin and vitamin K antagonists. Dig Liver Dis. 2016 Oct;48(10):1208-13. doi: 10.1016/j.dld.2016.06.027. Epub 2016 Jul 1. |
| 14836887 | Background | HARTERT H. [Thrombelastography, a method for physical analysis of blood coagulation]. Z Gesamte Exp Med. 1951;117(2):189-203. No abstract available. Undetermined Language. |
| 27311154 | Background | Collins S, MacIntyre C, Hewer I. Thromboelastography: Clinical Application, Interpretation, and Transfusion Management. AANA J. 2016 Apr;84(2):129-34. |
| 22670837 | Background | MacIvor D, Rebel A, Hassan ZU. How do we integrate thromboelastography with perioperative transfusion management? Transfusion. 2013 Jul;53(7):1386-92. doi: 10.1111/j.1537-2995.2012.03728.x. Epub 2012 Jun 7. No abstract available. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |