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

Traumatic Brain Injury Clinical Trial

Official title:

Dynamic Changes of Cerebrospinal Fluid Endostatin Concentrations in Patients With Severe Traumatic Brain Injury.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01846546
• Other study ID #: ES-TBI 10JC
• Status: Completed
• Start date: October 2006
• Est. completion date: April 2008

Study information

• Verified date: September 2020
• Source: Shanghai 6th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 82 Years

Eligibility

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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Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	Shanghai Sixth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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