Cerebrospinal Fluid Endostatin/Collagen XVIII Concentrations in Patients With Severe Traumatic Brain Injury

NCT01846546 | Completed

• 1 other identifier: ES-TBI 10JC
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Angiogenesis is an important pathophysiological response to traumatic brain injury (TBI) and modulated by pro- and anti-angiogenic factors. Recent studies have suggested that endogenous angiogenesis inhibitor endostatin/collagen XVIII might play an important role in the secondary brain injury following TBI. The aim of this study was to investigate early changes in the concentrations of CSF endostatin/collagen XVIII after TBI and evaluated the relations of endostatin/collagen XVIII to injury severity and clinical outcome. Endostatin/collagen XVIII concentrations were measured serially for 1 week after hospitalization by using the enzyme linked immunosorbent assay method in the cerebrospinal fluid of 30 patients with TBI and a Glasgow Coma Scale score of 8 or less on admission. Comparative analysis were used to determine if its serial changes correlate with the GCS score and prognosis. Receiver operating characteristic curve was used to appraise the value of CSF endostatin/collagen XVIII levels in predicting the prognosis of patients with severe head injury.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury;; Endostatin/collagen XVIII;; Cerebrospinal fluid;; Prognosis

Outcome Measures

Primary Outcomes (1)

• Enzyme-linked immunosorbent assay

  This assay employs the quantitative sandwich enzyme immunoassay technique. In brief, a monoclonal antibody specific for endostatin/collagen XVIII had been pre-coated onto a microplate.

  6 months

Study Arms (1)

Severe Traumatic Brain Injury

Patients with severe TBI (Glasgow Coma Scale GCS score of 8 or less) requiring continuous lumbar drainage of CSF

Eligibility Criteria

• Age: 16 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Of the 30 patients with severe TBI, twenty were male and ten were female. The patients' age ranged from 16 to 82 years, with mean age of 51.1 years. The mechanisms of trauma included motor vehicle collisions, falls, heavy strikes (patients who were hit by heavy objects such as bricks, sticks, or falling objects) and assaults. Types of lesions, as evidenced by radiologic and neurologic symptoms or signs, included cerebral contusions/lacerations, intracranial hematomas, brain stem injury and diffuse axonal injury.

You may qualify if:

• Patients with severe TBI (GCS score of 8 or less) requiring continuous lumbar drainage of CSF. Patients delivered within 4 h whose highest abbreviated injury score (AIS) was 3 or less (other than head injury) were considered to be isolated TBI cases and were included.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

Related Publications (1)

• Chen H, Xue LX, Cao HL, Chen SW, Guo Y, Gao WW, Ju SM, Tian HL. Endostatin/collagen XVIII is increased in cerebrospinal fluid after severe traumatic brain injury. Biomed Res Int. 2013;2013:402375. doi: 10.1155/2013/402375. Epub 2013 Sep 8.

  PMID: 24089677 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Heng-Li Tian, M.D., Ph.D.

  Shanghai 6th People's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 30, 2013
• First Posted: May 3, 2013
• Study Start: October 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: April 1, 2008
• Last Updated: September 7, 2020

Record last verified: 2020-09

Locations

CN (1)