CirrhosisNCT02484534
Thrombin Generation Test in Patient With Liver Cirrhosis
An observational study of Cirrhosis, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- How many people
- 36 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Feb 2015to 18 Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (men and women) who are hospitalized in internal and surgical wards with a diagnosis of cirrhosis of the liver.
Who may be able to join
- Cirrhosis patient MELD ( Model For End-Stage Liver Disease) above 12
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cirrhosis
- Keywords
- Coagulation Factor, cirrhosis
- Medical subject headings
- Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications of cirrhosis.
Complications of cirrhosis, such as ascites, bleeding Varicose veins, encephalopathy or thrombosis of the portal vein.
Measured: 3 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start26 Feb 2015
- Primary completion9 Dec 2015
- Study completion18 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAWI HAZZAN, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484534
- Sponsor's protocol ID
- EMC62-14
- Status last verified
- Aug 2017
- First submitted
- 21 Dec 2014
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombin Generation Test in Patient With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02484534
- Acronym / sponsor ID
- EMC62-14
- Conditions
- Cirrhosis
- Keywords
- Coagulation Factor, cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 26 Feb 2015 (actual)
- Primary completion
- 9 Dec 2015 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (men and women) who are hospitalized in internal and surgical wards with a diagnosis of cirrhosis of the liver.
Key inclusion criteria (1 listed)
- Cirrhosis patient MELD ( Model For End-Stage Liver Disease) above 12
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications of cirrhosis.
Time frame: 3 month.
Complications of cirrhosis, such as ascites, bleeding Varicose veins, encephalopathy or thrombosis of the portal vein.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications of cirrhosis. (time frame: 3 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.