Effect of Rosuvastatin on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Moderate Head Injury

Head Injury Clinical Trial

Official title:

Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329758
• Other study ID #: 26-06ROHI
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2006
• Last updated: June 23, 2010
• Start date: July 2006
• Est. completion date: October 2007

Study information

• Verified date: March 2009
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.

Description:

The head injury is a frequent problem of health, which produces high morbid-mortality. Today is the main cause of death and disability between 18 and 40 years. In addition it originates expensive expenses in health care systems.

Head injury produces damage by primary mechanisms related to impact, then by biochemical ways which are activated and they carry to secondary damage. Many studies have been conducted for explaining secondary injury, the majority conclude there is a kind of ischemic lesion related maybe with changes in cerebral flow and metabolism. The management today is trying to avoid progression in secondary damage without good outcome. Many drugs and measures has been ineffective.

In the last years has been demonstrated in head injury microvascular damage like stroke. Statins o inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for reduction in LDL. Experimental and clinical studies in stroke have shown improvement in outcome. The toxicity related to statin is myopathy and hepatopathy, both with low incidence without fatal cases. Rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins.

We have designed this study for demonstrate if the administration of rosuvastatin in the first 24 hours and by 10 days has improvement in amnesia and orientation, furthermore outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Man or woman >16 and <50 years with HI less 24 hours in progression and Glasgow between 9 y 12.

• Man or woman >16 and <50 years with HI and Glasgow l3, with lesions in TC scan.

• Acceptance of family to participate (first grade).

Exclusion Criteria:

• History of HI with disability

• History of neurological or psychiatric disease with disability.

• Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone.

• Existence of systemic injury with life in compromise (massive bleeding, exposition of bone in fracture, hepatic or splenic laceration or in great vessels and shock).

• Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters

• Existence of intracranial lesion which needs surgery.

• Lesions not classifiable or in brainstem.

• Allergy to the drug.

• Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease.

• Management previous in other Hospital.

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amnesia
• Craniocerebral Trauma
• Head Injury

Intervention

Drug:
• rosuvastatin
20 mg oral, during 10 days
• Placebo

Locations

Country	Name	City	State
Mexico	Hospital Central "Dr. Ignacio Morones Prieto"	San Luis Potosi

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí	AstraZeneca, Hospital Central "Dr. Ignacio Morones Prieto"

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo J, Rodriguez-Leyva I, Herrera-Gonzalez LB. [Statins and brain protection mechanisms]. Rev Neurol. 2007 Sep 16-30;45(6):359-64. Review. Spanish. — View Citation

Tapia-Perez J, Sanchez-Aguilar M, Torres-Corzo JG, Gordillo-Moscoso A, Martinez-Perez P, Madeville P, de la Cruz-Mendoza E, Chalita-Williams J. Effect of rosuvastatin on amnesia and disorientation after traumatic brain injury (NCT003229758). J Neurotrauma. 2008 Aug;25(8):1011-7. doi: 10.1089/neu.2008.0554. — View Citation

Tapia-Pérez JH, Sanchez-Aguilar M, Schneider T. The role of statins in neurosurgery. Neurosurg Rev. 2010 Jul;33(3):259-70; discussion 270. doi: 10.1007/s10143-010-0259-4. Epub 2010 Apr 29. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Galveston Orientation and Amnesia Test		Days in be positive	No
Secondary	Functional outcome by Disability Rating Scale		at 0 (release) and 3 months	No
Secondary	Cytosines (Il-1B, IL-6, TNF-alfa)		Basal and day 3	No
Secondary	acute renal Insuficience		Periode of medication (10 days)	Yes
Secondary	Lesion on CT scan		72 hours	No