NCT05170854

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
4,774,035

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress97%
Oct 2018Aug 2026

Study Start

First participant enrolled

October 16, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

December 28, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

May 1, 2026

Status Verified

August 1, 2025

Enrollment Period

7.8 years

First QC Date

August 12, 2019

Last Update Submit

April 27, 2026

Conditions

Cirrhosis

Keywords

cirrhotic trauma

Outcome Measures

Primary Outcomes (2)

  • Mortality

    Patient death

    2010-2018

  • Incidence of infectious complications

    Incidents of complications with infections

    2010-2018

Secondary Outcomes (17)

  • Patient demographics

    2010-2018

  • vital signs; clinical measurements

    2010-2018

  • vital signs; pulse rate

    2010-2018

  • vital signs; temperature

    2010-2018

  • vital signs; respiration rate

    2010-2018

  • +12 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • Patients less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Health System

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Parvez Mantry, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

December 28, 2021

Study Start

October 16, 2018

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 1, 2026

Record last verified: 2025-08

Locations

US(1)