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Magnesium Sulfate For Brain Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004730
First Posted: February 28, 2000
Last Update Posted: October 28, 2011
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.
Information provided by (Responsible Party):
Nancy Temkin, University of Washington
  Purpose
The purpose of the study is to determine whether magnesium sulfate, given within 8 hours of a moderate or severe traumatic brain injury improves survival, decreases the number of people developing seizures, improves the survivors' mental and psychological functioning, including the ability to return to daily life, live independently, and return to work or school.

Condition Intervention Phase
Brain Injuries Head Injury Brain Concussion Drug: magnesium sulfate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Magnesium Sulfate for Neuroprotection After Brain Trauma

Resource links provided by NLM:


Further study details as provided by Nancy Temkin, University of Washington:

Study Start Date: August 1998
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Detailed Description:
The purpose of the study is to determine if treating head-injured patients with magnesium sulfate will improve medical, mental, and psychological recovery. In particular, the study will assess each patient's ability to return to daily life, live independently, and return to work or school as done before the head injury occurred. The study will also assess magnesium sulfate's ability to reduce the risk of developing seizures (epilepsy) as well as to improve survival rates after a traumatic brain injury. Patients on the study are assigned randomly (by chance) to either the magnesium sulfate group or the group which gets a placebo. This means they have an equal chance of being in either group. Before the first dose is given, two teaspoons worth of blood are drawn from a vein in the arm. The first dose of magnesium sulfate is 1meq/kg given intravenously within 8 hours of injury. Then a five day continuous intravenous infusion of magnesium sulfate 0.24meq/kg per hour is begun. Daily magnesium levels are checked and the dose changed in order to keep the Magnesium blood level at approximately 4meq/L. If the person does not receive magnesium sulfate, he receives a placebo which looks just like magnesium sulfate but contains no active medication. If the person leaves the hospital before the five days are over, the magnesium or placebo is stopped. Patients on the study will receive a brief exam in person or over the phone at one and three months after the injury to determine whether they have had any seizures and to evaluate how they are functioning and recovering from their head injury. Each evaluation will last about one hour. At six months after the injury, they will have full neuropsychological and psychosocial evaluations done at Harborview. These tests will take about five hours to complete and include tests of vocabulary, problem solving, and coordination. There will be questions about how the injury has affected the way they feel and interact socially. For example, there will be questions about their ability to work, manage personal affairs, what their moods are like, and how anger is handled.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Traumatic brain injury with post-resuscitation Glasgow Coma Scale of 3-12 or, if intubated, motor score of 1-5, or who require emergent neurosurgical intervention precluding the accurate assessment of Glasgow Coma Scale.

Exclusion Criteria:

  • Injury greater than 8 hours old
  • Age under 14 years
  • Compromised renal function (creatinine of 2.0 mb/dl or greater)
  • Membership in a vulnerable population (e.g. pregnant woman, prisoner, etc.)
  • Residence making follow-up unlikely (e.g. lives outside U.S.)
  • Refusal to participate
  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): NCT00004730


Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Nancy Temkin, Ph.D. University of Washington
  More Information

Publications:
Responsible Party: Nancy Temkin, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00004730     History of Changes
Obsolete Identifiers: NCT00004484
Other Study ID Numbers: R01NS019643 ( U.S. NIH Grant/Contract )
First Submitted: February 25, 2000
First Posted: February 28, 2000
Last Update Posted: October 28, 2011
Last Verified: October 2011

Keywords provided by Nancy Temkin, University of Washington:
head injury
traumatic brain injury
concussion
magnesium sulfate
neuroprotection

Additional relevant MeSH terms:
Brain Concussion
Wounds and Injuries
Brain Injuries
Craniocerebral Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents


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