The Impact of Liver Cirrhosis on Outcomes in Trauma Patients | NCT05170854

Studies
The Impact of Liver Cirrhosis on Outcomes in Trauma Patients

NCT05170854

Sponsor

Methodist Health System

Status

Completed

Last Update Posted

Jun 10, 2026Actual

Enrollment

4,774,035Actual

Phase

Not provided

Conditions

Cirrhosis

Interventions

Not provided

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

Aug 2025

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

Oct 16, 2018Actual

Primary Completion Date

Sep 3, 2020Actual

Completion Date

Sep 4, 2020Actual

First Submitted Date

Aug 12, 2019

First Submission Date that Met QC Criteria

Dec 9, 2021

First Posted Date

Dec 28, 2021Actual

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

Jun 8, 2026

Last Update Posted Date

Jun 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Given that there are only a few studies on the effects of cirrhosis on trauma patients and none have addressed the impact cirrhosis has on the incidence of infections, it is important that we study this to determine the mortality in cirrhotic trauma patients and ascertain the incidence of infectious complications in these patients. We hypothesize that trauma patients with cirrhosis will have higher rates of mortality and infectious complications.

Detailed Description

There have been a select few studies addressing the effects of cirrhosis on trauma patients. These studies show an increase in morbidity and mortality. However, there is limitation in the depth and breadth of analysis. The primary aim of this study is to determine the mortality rates in cirrhotic trauma patients with a secondary end-point being the determination of the incidence of infections associated with these patients.

Given that there are only a few studies on the effects of cirrhosis on trauma patients and none have addressed the impact cirrhosis has on the incidence of infections, it is important that we study this to determine the mortality in cirrhotic trauma patients and ascertain the incidence of infectious complications in these patients. PI hypothesizes that trauma patients with cirrhosis will have higher rates of mortality and infectious complications.

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

4,774,035Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Patient death	2010-2018
Incidence of infectious complications	Incidents of complications with infections	2010-2018

Secondary Outcomes

Measure	Description	Time Frame
Patient demographics	demographics of patients	2010-2018
vital signs; clinical measurements	clinical measurements	2010-2018

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cirrhotic trauma patients in the United States within 2010-2018
Patients ≥ 18 years old

Exclusion Criteria:

Patients less than 18 years old

Accepts Healthy Volunteers

Not provided

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 confirmed diagnosis of cirrhosis via radiologic, laboratory profile and intraoperative findings will be selected.Data will be extracted from the NTDB & TQIP databanks from 2010-2018.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Parvez Mantry, MD	The Methodist Hospital Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Health System		Dallas	Texas	75203	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

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Browse Branches

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