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

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ClinicalTrials.gov Identifier: NCT00329758
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : June 24, 2010
Sponsor:
Collaborators:
Hospital Central "Dr. Ignacio Morones Prieto"
AstraZeneca
Information provided by:
Universidad Autonoma de San Luis Potosí

Brief 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.

Condition or disease Intervention/treatment Phase
Head Injury Drug: rosuvastatin Drug: Placebo Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : July 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Head Injuries
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Drug: rosuvastatin
20 mg oral, during 10 days
Other Name: Crestor
Placebo Comparator: 2 Drug: Placebo



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

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


Information from the National Library of Medicine

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

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

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


Locations
Mexico
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"
AstraZeneca
Investigators
Study Director: Jaime Torres-Corzo, Neurosurgeon Hospital Central "Dr. Ignacio Morones Prieto"
Principal Investigator: Humberto Tapia-Perez, MD Facultad de Medicina UASLP

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

Keywords provided by Universidad Autonoma de San Luis Potosí:
moderate head injury
rosuvastatin
statin
amnesia
orientation

Additional relevant MeSH terms:
Wounds and Injuries
Craniocerebral Trauma
Amnesia
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors