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Thrombin Generation Test in Patient With Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT02484534
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
RAWI HAZZAN, HaEmek Medical Center, Israel

Study Description
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Brief Summary:

Cirrhotic patients are patients with high morbidity and mortality, it is very important for determining the prognosis of these patients. The importance increases when these patients waiting for a liver transplant. The Model for End-Stage Liver Disease (MELD) is a reliable measure of mortality risk in patients with end-stage liver disease. It is used as a disease severity index to help prioritize allocation of organs for transplant. MELD uses the patient values for serum bilirubin, serum creatinine, and the international normalized ratio for prothrombin time (INR) to predict survival.

Blood tests that we use today in daily practice to evaluate the coagulation system (PT, PTT) do not check actually the functioning of the system, but examine the level of clotting factors and therefore only verify that the side of Anticoagulant of the equation and not the side of the procoagulant .

To examine the coagulation system function tests have been developed, One of them is the thrombin generation. The purpose of the trial is to determine whether thrombin generation test can be a prognostic indicator in patients cirrhosis.


Condition or disease
Cirrhosis

Study Design
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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thrombin Generation Test in Patient With Liver Cirrhosis
Actual Study Start Date : February 26, 2015
Actual Primary Completion Date : December 9, 2015
Actual Study Completion Date : January 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
Drug Information available for: Thrombin

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Complications of cirrhosis. [ Time Frame: 3 month. ]
    Complications of cirrhosis, such as ascites, bleeding Varicose veins, encephalopathy or thrombosis of the portal vein.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients (men and women) who are hospitalized in internal and surgical wards with a diagnosis of cirrhosis of the liver.
Criteria

Inclusion Criteria:

Cirrhosis patient MELD ( Model For End-Stage Liver Disease) above 12

Exclusion Criteria:

Pregnant women

Contacts and Locations
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Information from the National Library of Medicine

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): NCT02484534


Locations
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Israel
Haemek medical center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
More Information
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Responsible Party: RAWI HAZZAN, dr, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT02484534    
Other Study ID Numbers: EMC62-14
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Keywords provided by RAWI HAZZAN, HaEmek Medical Center, Israel:
Coagulation Factor
cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases