NCT00329758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

June 24, 2010

Status Verified

March 1, 2009

Enrollment Period

1.3 years

First QC Date

May 23, 2006

Last Update Submit

June 23, 2010

Conditions

Head Injury

Keywords

moderate head injuryrosuvastatinstatinamnesiaorientation

Outcome Measures

Primary Outcomes (1)

  • Galveston Orientation and Amnesia Test

    Days in be positive

Secondary Outcomes (4)

  • Functional outcome by Disability Rating Scale

    at 0 (release) and 3 months

  • Cytosines (Il-1B, IL-6, TNF-alfa)

    Basal and day 3

  • acute renal Insuficience

    Periode of medication (10 days)

  • Lesion on CT scan

    72 hours

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: rosuvastatin

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

rosuvastatinDRUG

20 mg oral, during 10 days

Also known as: Crestor
1
PlaceboDRUG
2

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, 78240, Mexico

Location

Related 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. Spanish.

    PMID: 17899518BACKGROUND

  • 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.

    PMID: 18690806BACKGROUND

  • Tapia-Perez 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.

    PMID: 20429022BACKGROUND

MeSH Terms

Conditions

Craniocerebral TraumaAmnesiaOrientation, Spatial

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesMemory DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersSpatial BehaviorBehavior

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jaime Torres-Corzo, Neurosurgeon

    Hospital Central "Dr. Ignacio Morones Prieto"

    STUDY DIRECTOR

  • Humberto Tapia-Perez, MD

    Facultad de Medicina UASLP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 25, 2006

Study Start

July 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

June 24, 2010

Record last verified: 2009-03

Locations

ME(1)