Observational Endothelin and Markers of Cellular Apoptosis In CSF Head Injury

Completed

Conditions studied: Cerebrovascular Trauma, Neurohormones, Cellular Apoptosis, Endothelin System

In brief

The goal of this study is to answer the following questions: * What is the time course of the expected changes in endothelin levels during the first two weeks after injury and how does this relate to outcome? * What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and cerebrospinal fluid and type of injury, from CT scans and GCS? * What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and cerebrospinal fluid and outcome measurements like GOSE, ICP and CT scans? * What is the relation between neurohormones related to the neutral endopeptidase (NEP) (ANP, BNP and cGMP) in plasma and cerebrospinal fluid and type of injury, from CT scans and GCS? * What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and cerebrospinal fluid and markers for apoptosis?

Key facts

Study ID

NCT00498498

Run by

Virginia Commonwealth University

People needed

51

Starts

2007-07-01

Expected to finish

2009-12-01

Last updated by the study team

2011-11-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained before collection of blood and CSF is commenced.
• TBI diagnosed by history, clinical examination with GCS of 8 or less, and head CT scan and placement of ventriculostomy catheter
• Patients with GCS 9 -12 who undergo placement of a ventriculostomy because of the severity of the CT lesion may be included
• Patients will be enrolled in the study within the first 8 hours after injury
• At least one reactive pupil after injury
• Age 18-70

You may not qualify if…

• Life expectancy of less than 8 hours as determined by the investigator
• Associated spinal cord injury
• Patients with penetrating head injury will be excluded
• Inability to establish ventriculostomy drainage
• Severe cardiac or hemodynamic instability consistent with point #1 above
• blood pressure less than 65mmHg mean, will be an exclusion criteria.
• Receipt of any known investigational drug within 30 days prior to this study

Where it is running

• University of California, Davis — Sacramento, California, United States
• Harbor UCLA Medical Center — Torrance, California, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• The Mayfield Clinic — Cincinnati, Ohio, United States
• University of Tennessee Health Science Center — Memphis, Tennessee, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University Hospital Heidelberg — Heidelberg, Germany
• University of Padova Medical School — Padova, Italy
• Vall d'Hebron University Hospital — Barcelona, Spain

Full record on ClinicalTrials.gov

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