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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:

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.


Sponsor: Universidad Autonoma de San Luis Potosí

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

Original Primary Outcome: Time in be positive Galveston Orientation and Amnesia Test

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Changes daily in Glasgow Coma Scale
  • Days of stay in hospital
  • Funcional outcome by Disabilty Rating Scale and Glasgow Outcome Scale at 0 and 3 months
  • Changes in transcranial doppler measurement


Information By: Universidad Autonoma de San Luis Potosí

Dates:
Date Received: May 23, 2006
Date Started: July 2006
Date Completion:
Last Updated: June 23, 2010
Last Verified: March 2009