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

June 23, 2010 updated by: Universidad Autonoma de San Luis Potosí

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • San Luis Potosi, Mexico, 78240
        • Hospital Central "Dr. Ignacio Morones Prieto"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
Active Comparator: 1
Drug: rosuvastatin
20 mg oral, during 10 days
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Galveston Orientation and Amnesia Test
Time Frame: Days in be positive
Days in be positive

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Autonoma de San Luis Potosí

Collaborators

AstraZeneca
Hospital Central "Dr. Ignacio Morones Prieto"

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

May 23, 2006

First Submitted That Met QC Criteria

May 23, 2006

First Posted (Estimate)

May 25, 2006

Study Record Updates

Last Update Posted (Estimate)

June 24, 2010

Last Update Submitted That Met QC Criteria

June 23, 2010

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-06ROHI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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