Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic

NCT03580577 | Unknown

• 1 other identifier: Liver cirrhosis and thrombosis
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis; Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• detect safety of anticoagulants in cirrhotic

  During treatment period wither 12 or 24 weeks from starting therapy

• Correlate thromboelastography results with hypercoagluable state in cirrhotic patients with venous thromboembolism

  1 day

Study Arms (2)

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. * Patients will start treatment with anticoagulants therapy after liaise with the specialized physician. * Protein C, protein S and antithrombin III level will be assessed 3 months after the acute thrombotic event and 1 month of vitamin K antagonist (VKA) withdrawal.

Device: thromboelastography

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.

Interventions

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

Cirrhotic with venous thromboembolism

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

liver cirrhosis patients with acute venous thromboembolism (VTE), control group of cirrhotic patients without VTE

You may qualify if:

• all cirrhotic patient who developed venous thromboembolic events
• written informed consent (patient or nearest relative )

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (12)

• 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.

  PMID: 18443906 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.

  PMID: 16863556 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.

  PMID: 28088580 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.

  PMID: 19706293 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.

  PMID: 23583273 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.

  PMID: 16871542 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.

  PMID: 15726661 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.

  PMID: 3016943 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.

  PMID: 27470055 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.

  PMID: 14836887 BACKGROUND

• Collins S, MacIntyre C, Hewer I. Thromboelastography: Clinical Application, Interpretation, and Transfusion Management. AANA J. 2016 Apr;84(2):129-34.

  PMID: 27311154 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.

  PMID: 22670837 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Venous Thromboembolism

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Mohamed Abdel Sabour Mohamed Mekky

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Radwan Riad

CONTACT

+2 01126435001; dr.radwan1988@gmail.com

Mohamed Abdel Sabour Mohamed Mekky

CONTACT

mmekky75@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 16, 2018
• First Posted: July 9, 2018
• Study Start: September 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: September 1, 2019
• Last Updated: July 30, 2018

Record last verified: 2018-07

Locations

EG (1)