Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic
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| ClinicalTrials.gov Identifier: NCT03580577 |
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Recruitment Status : Unknown
Verified July 2018 by Ahmed Radwan Riad, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : July 9, 2018
Last Update Posted : July 30, 2018
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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.
| Condition or disease | Intervention/treatment |
|---|---|
| Liver Cirrhosis Venous Thromboembolism | Device: thromboelastography |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 60 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic Patients: A Hospital Based Prospective Study |
| Estimated Study Start Date : | September 1, 2018 |
| Estimated Primary Completion Date : | June 30, 2019 |
| Estimated Study Completion Date : | September 1, 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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Device: thromboelastography
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 |
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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. |
- Occurence of recanalization of thrombosed vessel [ Time Frame: 24 weeks from baseline ]Efficacy of anticoagulants describe its ability to prevent further thrombosis and restore patency of thrmobosed vessel
- detect safety of anticoagulants in cirrhotic [ Time Frame: During treatment period wither 12 or 24 weeks from starting therapy ]Occurrence of any bleeding event while on anticoagulants therapy
- Correlate thromboelastography results with hypercoagluable state in cirrhotic patients with venous thromboembolism [ Time Frame: 1 day ]Changes in r, k and MA- TEG parameters in cirrhotic patients with venous thromboembolism
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- all cirrhotic patient who developed venous thromboembolic events
- written informed consent (patient or nearest relative )
Exclusion Criteria:
- Patient with chronic thromboembolic event ( e.g. chronic pulmonary embolism, chronic portal vein thrombosis).
- patients on antiplatelets or anticoagulants.
- Patients with end stage kidney, heart or lung diseases
- Pregnant.
- Cirrhotic patients on control group who develop an acute thromboembolic event during the study period will be excluded and shifted to the case group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580577
| Contact: Ahmed Radwan Riad | +2 01126435001 | dr.radwan1988@gmail.com | |
| Contact: Mohamed Abdel Sabour Mohamed Mekky | mmekky75@yahoo.com |
| Egypt | |
| Assiut university | |
| Assiut, Egypt | |
| Study Director: | Mohamed Abdel Sabour Mohamed Mekky | Assiut University |
| Responsible Party: | Ahmed Radwan Riad, Assistant lecturer, Assiut University |
| ClinicalTrials.gov Identifier: | NCT03580577 |
| Other Study ID Numbers: |
Liver cirrhosis and thrombosis |
| First Posted: | July 9, 2018 Key Record Dates |
| Last Update Posted: | July 30, 2018 |
| Last Verified: | July 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Liver Cirrhosis Thromboembolism Venous Thromboembolism Fibrosis Pathologic Processes |
Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Liver Diseases Digestive System Diseases |