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Sponsors and Collaborators: |
Virginia Commonwealth University Solvay Pharmaceuticals |
Information provided by: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00498498 |
The goal of this study is to answer the following questions:
Condition |
Cerebrovascular Trauma Neurohormones Cellular Apoptosis Endothelin System |
MedlinePlus related topics: | Head and Brain Injuries Injuries Wounds |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | A Multicenter Observational Study to Evaluate Dynamics of Endothelin and Markers of Cellular Apoptosis in Cerebrospinal Fluid and Plasma in Moderate and Severe Human Head Injury |
CSF, plasma
Estimated Enrollment: | 50 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | October 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Severe traumatic brain injury (TBI) remains a critical problem in the United States and throughout the world. Advances in critical care of the TBI patient has resulted in improved outcome. However, despite these efforts, half of the patients with severe brain injury die or are left with severe disability. Thus, the need for a pharmaceutical agent to blunt the cascade of neurotoxins released with mechanical head trauma and improve outcome is critically important. One of these neurotoxins is endothelin, a potent vasoactive peptide, which is considered to play a major role in TBI, particularly with subarachnoid hemorrhage and concomitant vasospasm. However, relatively little is known regarding the up-regulation of this toxin after head injury. Thus, the purpose of this observational study is to document the levels of endothelin in cerebrospinal fluid and plasma of patients with brain injury over a 14 day period. Aliquots of CSF and blood will be obtained at 12 hour intervals as long as a ventriculostomy for sampling of CSF is required for routine management. Additional information regarding the severity of injury, CT pathology, intracranial pressure, neurologic assessment, CSF biomarkers, and transcranial doppler ultrasound will also be collected. The study will be implemented among 12 centers,8 in the U.S.A and 3 in Europe and 1 in Canada, providing an average of approximately 5 patients per center over a period of 7 months. The study may be extended based on an interim analysis of endothelin levels at various injury severity levels. Data will be collected and coordinated by the American Brain Injury Consortium utilizing a web-based entry system. Following the completion of accrual a final report will be assembled by the ABIC which will serve as the basis for scientific publication and provide reference data for future development of clinical trials utilizing the endothelin system.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Fifty patients will be enrolled in this trial. Subjects will be eligible who have severe traumatic brain injury (the majority of patients) or moderate TBI together with lesions on CT scans sufficient to warrant placement of ventriculostomy catheter.
Inclusion Criteria:
Exclusion Criteria:
Contact: Anthony Marmarou, PhD | 804-828-8892 | marmarou@vcu.edu |
Contact: John Ward, MD | 804-828-4478 | jdward@vcu.edu |
United States, California | |||||
Harbor UCLA Medical Center | Recruiting | ||||
Torrance, California, United States, 90509 | |||||
Contact: Duc Duong, MD, FACS 310-222-2754 ducduong@cdrewu.edu | |||||
Contact: Marcia Montenegro, RN 310.222.2754 mmontenegro07@yahoo.com | |||||
Principal Investigator: Duc H Duong, MD, FACS | |||||
University of California, Davis | Active, not recruiting | ||||
Sacramento, California, United States, 95817 | |||||
United States, Florida | |||||
University of Miami Miller School of Medicine | Not yet recruiting | ||||
Miami, Florida, United States, 33136 | |||||
Contact: M R Bullock, MD | |||||
Contact: Nicia Diaz 305-243-2088 NDiaz@med.miami.edu | |||||
Principal Investigator: M R Bullock, MD | |||||
United States, Iowa | |||||
University of Iowa Hospital | Recruiting | ||||
Iowa City, Iowa, United States, 52242 | |||||
Contact: Patrick Hitchon, MD 319-356-2775 patrick-hitchon@uiowa.edu | |||||
Contact: Marjory E Rogers, RN 319-353-6616 marjory-rogers@uiowa.edu | |||||
Principal Investigator: Patrick Hitchon, MD | |||||
United States, Kentucky | |||||
University of Kentucky | Recruiting | ||||
Lexington, Kentucky, United States, 40536 | |||||
Contact: A B Young, MD 859-323-5864 byoun1@uky.edu | |||||
Contact: Nurdan Ilglas, BA,CCRP 859-323-0375 nshaf2@uky.edu | |||||
Principal Investigator: A B Young, MD | |||||
United States, Ohio | |||||
The Mayfield Clinic | Recruiting | ||||
Cincinnati, Ohio, United States, 45219 | |||||
Contact: Raj K Narayan, MD 513-558-3557 raj.narayan@uc.edu | |||||
Contact: Suzanne Kempisty, RN 513-558-3590 suzanne.kempisty-cliver@uc.edu | |||||
Principal Investigator: Raj K Narayan, MD | |||||
United States, Tennessee | |||||
University of Tennessee Health Science Center | Recruiting | ||||
Memphis, Tennessee, United States, 38163 | |||||
Contact: Shelly Timmons, MD 901-448-4823 stimmons@utmem.edu | |||||
Principal Investigator: Shelly Timmons, MD | |||||
United States, Virginia | |||||
Virginia Commonwealth University | Recruiting | ||||
Richmond, Virginia, United States, 23298 | |||||
Contact: Anthony Marmarou, PhD 804-828-8892 marmarou@vcu.edu | |||||
Contact: John Ward, MD 804-828-4489 jdward@vcu.edu | |||||
Virginia Commonwealth University | Recruiting | ||||
Richmond, Virginia, United States, 23298 | |||||
Contact: Harold F. Young, MD 804-828-0165 hyoung@mcvh-vcu.edu | |||||
Contact: Charlotte Gilman, RN 804-828-9882 cgilman@mcvh-vcu.edu | |||||
Principal Investigator: Harold F. Young, MD | |||||
Canada, Ontario | |||||
St. Michael's Hospital | Withdrawn | ||||
Toronto, Ontario, Canada, ON M5B 1W8 | |||||
Germany | |||||
University Hospital Heidelberg | Recruiting | ||||
Heidelberg, Germany, D-69120 | |||||
Contact: Oliver W Sakowitz, MD 49 6221 56 36172 oliver.sakowitz@med.uni-heidelberg.dc | |||||
Contact: Andeas Unterberg, MD 49 6221 56 630` andreas.unterberg@med.uni-heidelberg.dc | |||||
Principal Investigator: Andreas Unterberg, MD | |||||
Italy | |||||
University of Padova Medical School | Recruiting | ||||
Padova, Italy, 35128 | |||||
Contact: Domenico d'Avella, MD 390 498 32 3648 domenico.davella@unipd.it | |||||
Principal Investigator: Domenico d'Avella, MD | |||||
Spain | |||||
Vall d'Hebron University Hospital | Recruiting | ||||
Barcelona, Spain, 08035 | |||||
Contact: Juan Sahquillo, MD 34 93 489 3512 sahuquillo@neurotrauma.net | |||||
Contact: M A Merino 34 93 489 3512 mamirno@neurotrauma.net | |||||
Principal Investigator: Juan Sahuquillo, MD |
Virginia Commonwealth University |
Solvay Pharmaceuticals |
Principal Investigator: | Anthony Marmarou, PHD | VCU |
Principal Investigator: | John Ward, MD | Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University ( Anthony Marmarou, PhD ) |
Study ID Numbers: | S001.2, S001, S001.1, S001.2 |
First Received: | July 9, 2007 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00498498 |
Health Authority: | United States: Institutional Review Board |
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