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CompletedNCT02510573

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
128 (actual)
Sponsor
Sanmen People's Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Accepted

Summary

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.

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.

Conditions

Timeline

Start date
2011-04-01
Primary completion
2014-07-01
Completion
2015-02-01
First posted
2015-07-29
Last updated
2015-07-29

Source: ClinicalTrials.gov record NCT02510573. Inclusion in this directory is not an endorsement.