Magnesium Sulfate For Brain Injury

NCT ID: NCT00004730

Last Updated: 2011-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31
• Study Completion Date: 2005-05-31

Brief Summary

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.

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.

Conditions

Brain Injuries; Head Injury; Brain Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

magnesium sulfate

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Nancy Temkin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nancy Temkin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

Temkin NR, Anderson GD, Winn HR, Ellenbogen RG, Britz GW, Schuster J, Lucas T, Newell DW, Mansfield PN, Machamer JE, Barber J, Dikmen SS. Magnesium sulfate for neuroprotection after traumatic brain injury: a randomised controlled trial. Lancet Neurol. 2007 Jan;6(1):29-38. doi: 10.1016/S1474-4422(06)70630-5.

Reference Type: RESULT

PMID: 17166799 (View on PubMed)

Other Identifiers

R01NS019643

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00004484

Identifier Type: -

Identifier Source: nct_alias