CirrhosisNCT02737345
Correlation of Hepatitis C, Alcoholic Liver Disease, and Renal Failure With Hyperfibrinolysis in Liver Failure
An observational study of Cirrhosis, run by Scott Allen at 1 site in United States.
Trial summary
1. Further characterize the incidence of hyperfibrinolysis in cirrhotics 2. Correlate hyperfibrinolysis with 1. hepatitis C 2. alcoholic liver disease 3. the subset of a\&b with renal failure with and without dialysis 3. Better describe the hyperfibrinolytic ROTEM profile in cirrhotics Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Rotem
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2015to 1 Apr 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 with liver failure who are on the liver transplant waiting list
Who may be able to join
- Be on the the liver transplant waiting list
Who cannot join
- liver failure without eligibility for transplant
Trial locations and contacts
1 site in 1 country.
About this study
- Further characterize the incidence of hyperfibrinolysis in cirrhotics
- Correlate hyperfibrinolysis with
- hepatitis C
- alcoholic liver disease
- the subset of a\&b with renal failure with and without dialysis
- Better describe the hyperfibrinolytic ROTEM profile in cirrhotics
- Conditions
- Cirrhosis
- Being tested
- Rotem
- Keywords
- fibrinolysis, liver transplant, thromboelastometry
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotemOther
| Study group | Role | What they receive |
|---|---|---|
| Waiting list | Patients on the liver transplant waiting list Receives: Other: Rotem |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who exhibit fibrinolysis
The percentage of patients who exhibit fibrinolysis, defined as a decrease in maximum clot firmness <15% within 60 minutes of sample run time.
Measured: Within 60 minutes of sample run time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study start1 Nov 2015
- Primary completion1 Apr 2017
- Study completion1 Apr 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scott Allen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Scott Allen, University of Utah
- Investigators
- Scott Allen, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737345
- Sponsor's protocol ID
- 00086371
- Status last verified
- Nov 2017
- First submitted
- 1 Apr 2016
- Last updated
- 8 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Hepatitis C, Alcoholic Liver Disease, and Renal Failure With Hyperfibrinolysis in Liver Failure
- ClinicalTrials.gov ID
- NCT02737345
- Acronym / sponsor ID
- 00086371
- Conditions
- Cirrhosis
- Keywords
- fibrinolysis, liver transplant, thromboelastometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Scott AllenUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 13 Apr 2016 (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.
- Further characterize the incidence of hyperfibrinolysis in cirrhotics
- Correlate hyperfibrinolysis with
- hepatitis C
- alcoholic liver disease
- the subset of a\&b with renal failure with and without dialysis
- Better describe the hyperfibrinolytic ROTEM profile in cirrhotics
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Waiting list | – | Other: RotemPatients on the liver transplant waiting list |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver failure who are on the liver transplant waiting list
Key inclusion criteria (1 listed)
- Be on the the liver transplant waiting list
Key exclusion criteria (1 listed)
- liver failure without eligibility for transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotem | Other | Waiting list |
Primary outcome
The percentage of patients who exhibit fibrinolysis
Time frame: Within 60 minutes of sample run time
The percentage of patients who exhibit fibrinolysis, defined as a decrease in maximum clot firmness <15% within 60 minutes of sample run time.
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 8 Nov 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.
Scott Allen, MD principal investigator
University of Utah
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 Scott Allen at 1 site in United States.
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 8 Nov 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 United States. 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?
The percentage of patients who exhibit fibrinolysis (time frame: Within 60 minutes of sample run time). 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 8 Nov 2017.