Traumatic Brain Injury |
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Clinical Trial: Cerebral Hemodynamic Effects of Hypertonic Solutions in Severly Head-Injured Patients
This study is not yet open for patient recruitment.
Verified by The University of Texas Health Science Center at San Antonio July 2005
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Traumatic Brain Injury Intracranial Hypertension | Drug: Mannitol vs. Hypertonic Saline | Phase IV |
MedlinePlus related topics: Brain Diseases; Head and Brain Injuries
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Expected Total Enrollment: 10
Study start: August 2005; Expected completion: June 2006
Last follow-up: June 2006; Data entry closure: June 2006
Eligibility
Inclusion Criteria:
- Patients with severe TBI (motor GCS score < 5)
- Age > 18 years
- Health care provider indicated a treatment of intracranial hypertension using hyperosmotic agent
Exclusion Criteria:
Location and Contact Information
Texas
Center for Neurosurgery Sciences - UTHSCSA - Surgical Intensive Care Unit (SICU), San Antonio, Texas, 78229, United States
Roman Hlatky, M.D. 210-567-5625 hlatky@uthscsa.edu
Roman Hlatky, M.D., Principal Investigator
Roman Hlatky, M.D., Principal Investigator, Center for Neurosurgical Sciences - UTHSC San Antonio
More Information
Publications
Miller JD, Becker DP, Ward JD, Sullivan HG, Adams WE, Rosner MJ. Significance of intracranial hypertension in severe head injury. J Neurosurg. 1977 Oct;47(4):503-16.
Doyle JA, Davis DP, Hoyt DB. The use of hypertonic saline in the treatment of traumatic brain injury. J Trauma. 2001 Feb;50(2):367-83. Review. No abstract available.
Wade CE, Kramer GC, Grady JJ, Fabian TC, Younes RN. Efficacy of hypertonic 7.5% saline and 6% dextran-70 in treating trauma: a meta-analysis of controlled clinical studies. Surgery. 1997 Sep;122(3):609-16.
Valadka AB, Robertson CS. Should we be using hypertonic saline to treat intracranial hypertension? Crit Care Med. 2000 Apr;28(4):1245-6. Review. No abstract available.
Berger S, Schurer L, Hartl R, Deisbock T, Dautermann C, Murr R, Messmer K, Baethmann A. 7.2% NaCl/10% dextran 60 versus 20% mannitol for treatment of intracranial hypertension. Acta Neurochir Suppl (Wien). 1994;60:494-8.
Worthley LI, Cooper DJ, Jones N. Treatment of resistant intracranial hypertension with hypertonic saline. Report of two cases. J Neurosurg. 1988 Mar;68(3):478-81.
Qureshi AI, Suarez JI, Bhardwaj A, Mirski M, Schnitzer MS, Hanley DF, Ulatowski JA. Use of hypertonic (3%) saline/acetate infusion in the treatment of cerebral edema: Effect on intracranial pressure and lateral displacement of the brain. Crit Care Med. 1998 Mar;26(3):440-6.
Qureshi AI, Wilson DA, Traystman RJ. Treatment of elevated intracranial pressure in experimental intracerebral hemorrhage: comparison between mannitol and hypertonic saline. Neurosurgery. 1999 May;44(5):1055-63; discussion 1063-4.
Vialet R, Albanese J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7.
Battison C, Andrews PJ, Graham C, Petty T. Randomized, controlled trial on the effect of a 20% mannitol solution and a 7.5% saline/6% dextran solution on increased intracranial pressure after brain injury. Crit Care Med. 2005 Jan;33(1):196-202; discussion 257-8.
Cruz J, Minoja G, Okuchi K, Facco E. Successful use of the new high-dose mannitol treatment in patients with Glasgow Coma Scale scores of 3 and bilateral abnormal pupillary widening: a randomized trial. J Neurosurg. 2004 Mar;100(3):376-83.
Tseng MY, Al-Rawi PG, Pickard JD, Rasulo FA, Kirkpatrick PJ. Effect of hypertonic saline on cerebral blood flow in poor-grade patients with subarachnoid hemorrhage. Stroke. 2003 Jun;34(6):1389-96. Epub 2003 May 1.
Last Updated: August 1, 2005
Record first received: July 29, 2005
ClinicalTrials.gov Identifier: NCT00125229
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-02
Resources
- Brain Injury (Centers for Disease Control and Prevention)
- Brain Injury (National Institute of Neurological Disorders and Stroke)

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