NCT02484534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

February 26, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2017

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

December 21, 2014

Last Update Submit

August 9, 2017

Conditions

Keywords

Coagulation Factorcirrhosis

Outcome Measures

Primary Outcomes (1)

  • Complications of cirrhosis.

    Complications of cirrhosis, such as ascites, bleeding Varicose veins, encephalopathy or thrombosis of the portal vein.

    3 month.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients (men and women) who are hospitalized in internal and surgical wards with a diagnosis of cirrhosis of the liver.

You may qualify if:

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

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek medical center

Afula, Israel

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

December 21, 2014

First Posted

June 29, 2015

Study Start

February 26, 2015

Primary Completion

December 9, 2015

Study Completion

January 18, 2017

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations