Thrombin Generation Test in Patient With Liver Cirrhosis

Cirrhosis Clinical Trial

Official title:

Thrombin Generation Test in Patient With Liver Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484534
• Other study ID #: EMC62-14
• Status: Completed
• Phase: N/A
• First received: December 21, 2014
• Last updated: August 9, 2017
• Start date: February 26, 2015
• Est. completion date: January 18, 2017

Study information

• Verified date: August 2017
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 18, 2017
• Est. primary completion date: December 9, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
Israel	Haemek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications of cirrhosis.	Complications of cirrhosis, such as ascites, bleeding Varicose veins, encephalopathy or thrombosis of the portal vein.	3 month.