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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hao Chen, Shanghai Sixth People's Hospital
ClinicalTrials.gov Identifier:
NCT01846546
First received: April 30, 2013
Last updated: May 1, 2013
Last verified: April 2013
  Purpose

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.


Condition
Traumatic Brain Injury

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Dynamic Changes of Cerebrospinal Fluid Endostatin Concentrations in Patients With Severe Traumatic Brain Injury.

Resource links provided by NLM:


Further study details as provided by Shanghai Sixth People's Hospital:

Primary Outcome Measures:
  • Enzyme-linked immunosorbent assay [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Biospecimen Retention:   Samples Without DNA

Cerebrospinal fluid


Enrollment: 30
Study Start Date: October 2006
Study Completion Date: April 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
Severe Traumatic Brain Injury
Patients with severe TBI (Glasgow Coma Scale GCS score of 8 or less) requiring continuous lumbar drainage of CSF

Detailed Description:

Patients with severe TBI (Glasgow Coma Scale score of 8 or less) requiring continuous lumbar drainage of CSF were included in the study. Patients delivered within 4 h whose highest abbreviated injury score was 3 or less (other than head injury) were considered to be isolated TBI cases and were included. To avoid interfering factors, patients who suffered open or combined injuries, had existing prior neurological disease were excluded. Those who died within the first week of hospitalization and/or whose serial cerebrospinal fluid samples could not be obtained were also excluded as having incomplete data. Accordingly, 30 patients were analyzed in this study. Demographic data, including age, gender, mechanism of trauma and GCS score at admission were documented when the patients arrived at the emergency room. The control group comprised 20 patients whose cerebrospinal fluid was examined via lumbar puncture for investigation of suspected neurological disease. All patients had normal neurological examination, negative imaging studies, and none had evidence of trauma or preexisting neurological disease, including tumors, vascular anomalies, or abnormalities of cerebrospinal fluid. The study had approval from the hospital ethics committee and informed consent for participating in the study was obtained from an appropriate member of each patient's family before performance of lumbar drainage.

  Eligibility

Ages Eligible for Study:   16 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria: Patients who suffered open or combined injuries, had existing prior neurological disease were excluded. Those who died within the first week of hospitalization and/or whose serial CSF samples could not be obtained were also excluded as having incomplete data.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01846546

Sponsors and Collaborators
Shanghai Sixth People's Hospital
Investigators
Principal Investigator: Hao Chen, M.D. Shanghai Sixth People's Hospital
  More Information

No publications provided by Shanghai Sixth People's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hao Chen, Doctor, Shanghai Sixth People's Hospital
ClinicalTrials.gov Identifier: NCT01846546     History of Changes
Other Study ID Numbers: ES-TBI 10JC
Study First Received: April 30, 2013
Last Updated: May 1, 2013
Health Authority: China: Science and Technology Commission of Shanghai Municipality

Keywords provided by Shanghai Sixth People's Hospital:
Traumatic brain injury;
Endostatin/collagen XVIII;
Cerebrospinal fluid;
Prognosis

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Endostatins
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014