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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 25, 2006
Last Update Posted: June 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Hospital Central "Dr. Ignacio Morones Prieto"
Information provided by:
Universidad Autonoma de San Luis Potosí
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.

Condition Intervention Phase
Head Injury Drug: rosuvastatin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury

Resource links provided by NLM:

Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:
  • Galveston Orientation and Amnesia Test [ Time Frame: Days in be positive ]

Secondary Outcome Measures:
  • Functional outcome by Disability Rating Scale [ Time Frame: at 0 (release) and 3 months ]
  • Cytosines (Il-1B, IL-6, TNF-alfa) [ Time Frame: Basal and day 3 ]
  • acute renal Insuficience [ Time Frame: Periode of medication (10 days) ]
  • Lesion on CT scan [ Time Frame: 72 hours ]

Enrollment: 20
Study Start Date: July 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: rosuvastatin
20 mg oral, during 10 days
Other Name: Crestor
Placebo Comparator: 2 Drug: Placebo

Detailed 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.


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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329758

Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi, Mexico, 78240
Sponsors and Collaborators
Universidad Autonoma de San Luis Potosí
Hospital Central "Dr. Ignacio Morones Prieto"
Study Director: Jaime Torres-Corzo, Neurosurgeon Hospital Central "Dr. Ignacio Morones Prieto"
Principal Investigator: Humberto Tapia-Perez, MD Facultad de Medicina UASLP
  More Information

Responsible Party: Humberto Tapia
ClinicalTrials.gov Identifier: NCT00329758     History of Changes
Other Study ID Numbers: 26-06ROHI
First Submitted: May 23, 2006
First Posted: May 25, 2006
Last Update Posted: June 24, 2010
Last Verified: March 2009

Keywords provided by Universidad Autonoma de San Luis Potosí:
moderate head injury

Additional relevant MeSH terms:
Wounds and Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors