Correlation of Hepatitis C, Alcoholic Liver Disease, and... | NCT02737345

Studies
Correlation of Hepatitis C, Alcoholic Liver Disease, and Renal Failure With Hyperfibrinolysis in Liver Failure

NCT02737345

Sponsor

Scott Allen

Status

Completed

Last Update Posted

Nov 8, 2017Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Cirrhosis

Interventions

Rotem

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2015Actual

Primary Completion Date

Apr 1, 2017Actual

Completion Date

Apr 1, 2017Actual

First Submitted Date

Apr 1, 2016

First Submission Date that Met QC Criteria

Apr 12, 2016

First Posted Date

Apr 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2017

Last Update Posted Date

Nov 8, 2017Actual

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Waiting list		Patients on the liver transplant waiting list	Other: Rotem

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rotem	Other		Waiting list

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be on the the liver transplant waiting list

Exclusion Criteria:

liver failure without eligibility for transplant

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott Allen, MD	University of Utah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Utah		Salt Lake City	Utah	84132	United States

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided