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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02510573
• Other study ID #: SM2015119
• Status: Completed
• Phase: N/A
• First received: July 18, 2015
• Last updated: July 26, 2015
• Start date: April 2011
• Est. completion date: February 2015

Study information

• Verified date: July 2015
• Source: Sanmen People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanmen People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality after severe traumatic brain injury	Using structure telephone interviews, follow-up was performed by 1 doctor who was blinded to clinical information.	Follow-up of 6 months	Yes
Secondary	Unfavorable outcome after severe traumatic brain injury	Using structure telephone interviews, follow-up was performed by 1 doctor who was blinded to clinical information.	Follow-up of 6 months	Yes