Cerebrospinal Fluid (CSF) Drainage and Cytokine Profiling in the Treatment of Acute Spinal Cord Injury (SCI) - Full Text View

Purpose

The overall purpose of this pilot study is to evaluate CSF drainage as a potential neuroprotective strategy after acute spinal cord injury (SCI).

Condition	Intervention
Spinal Cord Injuries	Procedure: CSF will be drained using an epidural catheter inserted via lumbar puncture for 72 hours.

MedlinePlus related topics:

Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Cerebrospinal Fluid (CSF) Drainage and Cytokine Profiling in the Treatment of Acute Spinal Cord Injury (SCI) - A Pilot Study

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

To evaluate the safety and feasibility of CSF drainage as a potential treatment for patients with acute SCI [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine if CSF drainage will improve neurologic function after acute SCI [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
To evaluate the temporal pattern of expression of inflammatory cytokines within the CSF [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	March 2008
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Intervention Details:

See Detailed Description

Show Detailed Description

Eligibility

Ages Eligible for Study:	17 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Injured subjects:

Complete or incomplete acute SCI between C0 and T11
Admitted within 48 hours of injury
Undergoing spinal decompressive surgery
Undergoing lumbar puncture for spinal anesthetic or myelography
Neurologically intact

Exclusion Criteria:

Pre-existing neurodegenerative disorder
Associated head or spine injury

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135278

Contacts


Contact: Allan Aludino	(604) 875-4111 ext 62837

Locations


Canada, British Columbia
	Vancouver General Hospital	Recruiting
	Vancouver, British Columbia, Canada, V5Z 1M9
	Contact: Alan Aludino (604) 875-4111 ext 62837
	Principal Investigator: Dr. Brian Kwon, MD

Sponsors and Collaborators

University of British Columbia

Investigators


Principal Investigator:	Dr. Brian Kwon, MD, PhD	University of British Columbia

More Information

Publications:

1. Ackerman LL, Traynelis VC (2002) Treatment of delayed-onset neurological deficit after aortic surgery with lumbar cerebrospinal fluid drainage. Neurosurgery 51: 1414-1421. 2. Amar AP, Levy ML (1999) Pathogenesis and pharmacological strategies for mitigating secondary damage in acute spinal cord injury. Neurosurgery 44: 1027-1039. 3. Bartholdi D, Schwab ME (1997) Expression of pro-inflammatory cytokine and chemokine mRNA upon experimental spinal cord injury in mouse: an in situ hybridization study. Eur J Neurosci 9: 1422-1438. 4. Bethea JR (2000) Spinal cord injury-induced inflammation: a dual-edged sword. Prog Brain Res 128: 33-42. 5. Bracken MB, Shepard MJ, Collins WF, Jr., Holford TR, Baskin DS, Eisenberg HM, Flamm E, Leo-Summers L, Maroon JC, Marshall LF, . (1992) Methylprednisolone or naloxone treatment after acute spinal cord injury: 1-year follow-up data. Results of the second National Acute Spinal Cord Injury Study. J Neurosurg 76: 23-31. 6. Bracken MB, Shepard MJ, Holford TR, Leo-Summers L, Aldrich EF, Fazl M, Fehlings M, Herr DL, Hitchon PW, Marshall LF, Nockels RP, Pascale V, Perot PL, Jr., Piepmeier J, Sonntag VK, Wagner F, Wilberger JE, Winn HR, Young W (1997) Administration of methylprednisolone for 24 or 48 hours or tirilazad mesylate for 48 hours in the treatment of acute spinal cord injury. Results of the Third National Acute Spinal Cord Injury Randomized Controlled Trial. National Acute Spinal Cord Injury Study. JAMA 277: 1597-1604. 7. Brewer KL, Bethea JR, Yezierski RP (1999) Neuroprotective effects of interleukin-10 following excitotoxic spinal cord injury. Exp Neurol 159: 484-493. 8. Carmel JB, Galante A, Soteropoulos P, Tolias P, Recce M, Young W, Hart RP (2001) Gene expression profiling of acute spinal cord injury reveals spreading inflammatory signals and neuron loss. Physiol Genomics 7: 201-213. 9. Carroccio A, Marin ML, Ellozy S, Hollier LH (2003) Pathophysiology of paraplegia following endovascular thoracic aortic aneurysm repair. J Card Surg 18: 359-366. 10. Cheung AT, Pochettino A, Guvakov DV, Weiss SJ, Shanmugan S, Bavaria JE (2003) Safety of lumbar drains in thoracic aortic operations performed with extracorporeal circulation. Ann Thorac Surg 76: 1190-1196. 11. Coplin WM, Avellino AM, Kim DK, Winn HR, Grady MS (1999) Bacterial meningitis associated with lumbar drains: a retrospective cohort study. J Neurol Neurosurg Psychiatry 67: 468-473. 12. Coselli JS, Lemaire SA, Koksoy C, Schmittling ZC, Curling PE (2002) Cerebrospinal fluid drainage reduces paraplegia after thoracoabdominal aortic aneurysm repair: results of a randomized clinical trial. J Vasc Surg 35: 631-639. 13. Crawford ES, Crawford JL, Safi HJ, Coselli JS, Hess KR, Brooks B, Norton HJ, Glaeser DH (1986) Thoracoabdominal aortic aneurysms: preoperative and intraoperative factors determining immediate and long-term results of operations in 605 patients. J Vasc Surg 3: 389-404. 14. Crawford ES, Rubio PA (1973) Reappraisal of adjuncts to avoid ischemia in the treatment of aneurysms of descending thoracic aorta. J Thorac Cardiovasc Surg 66: 693-704. 15. Csuka E, Morganti-Kossmann MC, Lenzlinger PM, Joller H, Trentz O, Kossmann T (1999) IL-10 levels in cerebrospinal fluid and serum of patients with severe traumatic brain injury: relationship to IL-6, TNF-alpha, TGF-beta1 and blood-brain barrier function. J Neuroimmunol 101: 211-221. 16. Drenger B, Parker SD, Frank SM, Beattie C (1997) Changes in cerebrospinal fluid pressure and lactate concentrations during thoracoabdominal aortic aneurysm surgery. Anesthesiology 86: 41-47. 17. Geisler FH, Coleman WP, Grieco G, Poonian D (2001) The Sygen multicenter acute spinal cord injury study. Spine 26: S87-S98. 18. Grady RE, Horlocker TT, Brown RD, Maxson PM, Schroeder DR (1999) Neurologic complications after placement of cerebrospinal fluid drainage catheters and needles in anesthetized patients: implications for regional anesthesia. Mayo Perioperative Outcomes Group. Anesth Analg 88: 388-392. 19. Hayashi M, Ueyama T, Nemoto K, Tamaki T, Senba E (2000) Sequential mRNA expression for immediate early genes, cytokines, and neurotrophins in spinal cord injury. J Neurotrauma 17: 203-218. 20. Horlocker TT, Wedel DJ, Benzon H, Brown DL, Enneking KF, Heit JA, Mulroy MF, Rosenquist RW, Rowlingson J, Tryba M, Yuan CS (2004) Regional anesthesia in the anticoagulated patient: defining the risks. Reg Anesth Pain Med 29: 1-12. 21. Kim GM, Xu J, Xu J, Song SK, Yan P, Ku G, Xu XM, Hsu CY (2001) Tumor necrosis factor receptor deletion reduces nuclear factor-kappaB activation, cellular inhibitor of apoptosis protein 2 expression, and functional recovery after traumatic spinal cord injury. J Neurosci 21: 6617-6625. 22. Kobrine AI, Doyle TF, Martins AN (1975) Autoregulation of spinal cord blood flow. Clin Neurosurg 22: 573-581.

Responsible Party:	University of British Columbia ( Dr. Brian Kwon )
Study ID Numbers:	C04-0584, V05-0160
First Received:	August 23, 2005
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00135278
Health Authority:	Canada: Health Canada