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

NCT02510573 | Completed DMC

• 1 other identifier: SM2015119
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Brain Injuries

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Unfavorable outcome after severe traumatic brain injury

  Follow-up of 6 months

Study Arms (1)

sTBI group

The patients with isolated head trauma and postresuscitation GCS score of 8 or less.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanmen People's Hospital: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

All blood samples from the patients at admission were collected in the tubes and centrifuged within 30 minutes at 1,000\*g for 15 minutes. The serum was removed and frozen at -70°C until measurement.

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurosurgery

Study Record Dates

• First Submitted: July 18, 2015
• First Posted: July 29, 2015
• Study Start: April 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: February 1, 2015
• Last Updated: July 29, 2015

Record last verified: 2015-07