NCT02737345

Brief Summary

  1. 1.Further characterize the incidence of hyperfibrinolysis in cirrhotics
  2. 2.Correlate hyperfibrinolysis with
  3. 3.hepatitis C
  4. 4.alcoholic liver disease
  5. 5.the subset of a\&b with renal failure with and without dialysis
  6. 6.Better describe the hyperfibrinolytic ROTEM profile in cirrhotics

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 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

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

1.4 years

First QC Date

April 1, 2016

Last Update Submit

November 6, 2017

Conditions

Cirrhosis

Keywords

fibrinolysisliver transplantthromboelastometry

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 60 minutes of sample run time

Study Arms (1)

Waiting list

Patients on the liver transplant waiting list

Other: Rotem

Interventions

RotemOTHER
Waiting list

Eligibility Criteria

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

Patients with liver failure who are on the liver transplant waiting list

You may qualify if:

  • Be on the the liver transplant waiting list

You may not qualify if:

  • liver failure without eligibility for transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Scott Allen, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 13, 2016

Study Start

November 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

US(1)