NCT00004730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 1998

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2000

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2000

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

October 28, 2011

Status Verified

October 1, 2011

Enrollment Period

6.8 years

First QC Date

February 25, 2000

Last Update Submit

October 26, 2011

Conditions

Brain InjuriesHead InjuryBrain Concussion

Keywords

head injurytraumatic brain injuryconcussionmagnesium sulfateneuroprotection

Interventions

magnesium sulfateDRUG

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

    PMID: 17166799RESULT

MeSH Terms

Conditions

Brain InjuriesCraniocerebral TraumaBrain ConcussionBrain Injuries, Traumatic

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesHead Injuries, ClosedWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Nancy Temkin, Ph.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2000

First Posted

February 28, 2000

Study Start

August 1, 1998

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

October 28, 2011

Record last verified: 2011-10

Locations

US(1)