Magnesium Sulfate For Brain Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nancy Temkin, University of Washington
ClinicalTrials.gov Identifier:
NCT00004730
First received: February 25, 2000
Last updated: October 26, 2011
Last verified: October 2011
  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-Blind
Primary Purpose: Treatment
Official Title: Magnesium Sulfate for Neuroprotection After Brain Trauma

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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: R01NS19643
Study First Received: February 25, 2000
Last Updated: October 26, 2011
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Brain Concussion
Craniocerebral Trauma
Brain Injuries
Wounds and Injuries
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on July 10, 2014