Completed

Magnesium Sulfate for Neuroprotection After Brain Trauma

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What is being tested

magnesium sulfate

Drug
Who is being recruted

Brain Diseases+8

+ Central Nervous System Diseases

+ Nervous System Diseases

Over 14 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 1998
See protocol details

Summary

Principal SponsorUniversity of Washington
Last updated: October 28, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1998

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Washington
Last updated: October 28, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 14 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesWounds and InjuriesWounds, NonpenetratingHead Injuries, ClosedTrauma, Nervous SystemBrain Injuries, TraumaticBrain ConcussionBrain InjuriesCraniocerebral Trauma

Criteria

1 inclusion criteria required to participate
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

6 exclusion criteria prevent from participating
Age under 14 years

Compromised renal function (creatinine of 2.0 mb/dl or greater)

Injury greater than 8 hours old

Membership in a vulnerable population (e.g. pregnant woman, prisoner, etc.)

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Washington

Seattle, United StatesOpen University of Washington in Google Maps
CompletedOne Study Center