Low Serum Ficolin-3 Levels on Admission Are Associated With Poor Outcomes After Severe Traumatic Brain Injury

July 26, 2015 updated by: Xiongwei Gao, Sanmen People's Hospital

Prognostic Value of Serum Ficolin-3 Levels After Severe Traumatic Brain Injury：A Pilot Study

The current study was designed to investigate the change of serum ficolin-3 levels and assess the prognostic predictive effect of serum ficolin-3 levels in the patients with severe traumatic brain injury.

Study Overview

Status

Completed

Conditions

Detailed Description

Complement activation is one of the pathological mechanisms that contribute to the secondary brain injury after traumatic brain injury. Ficolin-mediated lectin pathways of complement activation contribute to the pathogenesis of ischemic stroke and may be additive to complement-independent inflammatory processes. Lower serum ficolin-3 levels have been demonstrated to be highly associated with unfavorable outcome after ischemic stroke. This prospective observatory study was designed to investigate the relationship between serum ficolin-3 levels and 1-week mortality, 6-month mortality and 6-month unfavorable outcome (defined as Glasgow Outcome Scale score of 1-3) in patients with severe traumatic brain injury. This study recruited 128 patients and 128 sex- and age- matched healthy controls. Serum ficolin-3 levels on admission were measured by sandwich immunoassays. It was postulated that serum ficolin-3 levels were correlated with Glasgow Coma Scale scores and ficolin-3 was identified as an independent prognostic predictor for 1-week mortality, 6-month mortality and 6-month unfavorable outcome. Thus, it was proposed that lower serum ficolin-3 levels, correlated with injury severity reflected by Glasgow Outcome Scale scores, had the potential to be the useful, complementary tool to predict short- or long- term clinical outcome after severe traumatic brain injury.

Study Type

Observational

Enrollment (Actual)

128

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients with isolated head trauma and postresuscitation Glasgow Coma Scale score of 8 or less.

Description

Inclusion Criteria:

  • Isolated head trauma
  • Postresuscitation Glasgow Coma Scale score of 8 or less.

Exclusion Criteria:

  • Less than 18 years of age
  • Admission time > 6 hours
  • Previous head trauma
  • Neurological disease including ischemic or hemorrhagic stroke
  • Use of antiplatelet or anticoagulant medication
  • Diabetes mellitus
  • Hypertension
  • Presence of other prior systemic diseases including uremia, liver cirrhosis, malignancy, and chronic heart or lung disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
sTBI group
The patients with isolated head trauma and postresuscitation GCS score of 8 or less.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality after severe traumatic brain injury
Time Frame: Follow-up of 6 months
Using structure telephone interviews, follow-up was performed by 1 doctor who was blinded to clinical information.
Follow-up of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unfavorable outcome after severe traumatic brain injury
Time Frame: Follow-up of 6 months
Using structure telephone interviews, follow-up was performed by 1 doctor who was blinded to clinical information.
Follow-up of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanmen People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 18, 2015

First Submitted That Met QC Criteria

July 26, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)

July 29, 2015

Last Update Submitted That Met QC Criteria

July 26, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM2015119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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