- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004730
Magnesium Sulfate For Brain Injury
October 26, 2011 updated by: Nancy Temkin, University of Washington
Magnesium Sulfate for Neuroprotection After Brain Trauma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- University of Washington
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nancy Temkin, Ph.D., University of Washington
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1998
Primary Completion (ACTUAL)
May 1, 2005
Study Completion (ACTUAL)
May 1, 2005
Study Registration Dates
First Submitted
February 25, 2000
First Submitted That Met QC Criteria
February 25, 2000
First Posted (ESTIMATE)
February 28, 2000
Study Record Updates
Last Update Posted (ESTIMATE)
October 28, 2011
Last Update Submitted That Met QC Criteria
October 26, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Trauma, Nervous System
- Head Injuries, Closed
- Wounds, Nonpenetrating
- Brain Injuries, Traumatic
- Brain Injuries
- Wounds and Injuries
- Craniocerebral Trauma
- Brain Concussion
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anticonvulsants
- Calcium-Regulating Hormones and Agents
- Reproductive Control Agents
- Calcium Channel Blockers
- Tocolytic Agents
- Magnesium Sulfate
Other Study ID Numbers
- R01NS019643 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Injuries
-
Eunice Kennedy Shriver National Institute of Child...CompletedTraumatic Brain Injuries
-
Technical University of MunichFederal Ministry of Defence (Germany); Bundesministerium der VerteidigungRecruitingTraumatic Brain InjuriesFrance, Germany
-
University of Colorado, DenverBinghamton University; Brooke Army Medical CenterRecruitingBrain ConcussionUnited States
-
University of Alabama at BirminghamCompletedTraumatic Brain InjuriesUnited States
-
Mosaic Life CareMissouri Western State UniversityTerminatedBrain Injuries | Brain Concussion | Athletic Injuries | Diffuse Axonal Injury | Injury, Brain, TraumaticUnited States
-
Bayside HealthVictorian Trauma FoundationCompletedTraumatic Brain Injury | Multiple Trauma | Spinal InjuriesAustralia
-
La Trobe UniversityRecruitingAnterior Cruciate Ligament Injuries | Concussion, Brain | Musculoskeletal InjuryAustralia
-
More FoundationElMindA Ltd; Riddell, LLC; Mimic SystemsUnknownAthletic Injuries | Concussion, BrainUnited States
-
Association de Recherche Bibliographique pour les...University of Cambridge; Centre Hospitalier Princesse Grace; Institut National...CompletedBrain Injuries | Sport Injury | Concussion, BrainMonaco
-
Henry M. Jackson Foundation for the Advancement...U.S. Army Medical Research and Development CommandCompletedTraumatic Brain Injury | Brain ConcussionAfghanistan
Clinical Trials on magnesium sulfate
-
Aurora Health CareNot yet recruitingAtrial Fibrillation | Tachycardia Atrial | Atrial Flutter With Rapid Ventricular ResponseUnited States
-
University of OklahomaRecruitingAsthma in Children | Asthma AttackUnited States
-
Thomas Jefferson UniversityNot yet recruiting
-
Sohag UniversityRecruitingPost Operative Pain, AcuteEgypt
-
Sohag UniversityCompletedPersistent Pulmonary Hypertension of the Newborn | PPHN | Persistent Fetal CirculationEgypt
-
Instituto Materno Infantil Prof. Fernando FigueiraCompletedSevere PreeclampsiaBrazil
-
Queen Sirikit National Institute of Child HealthUnknownAcute Severe AsthmaThailand
-
Assiut UniversityRecruitingIntracranial Pressure Control in Pre-eclampsiaEgypt
-
University of Texas Southwestern Medical CenterCompletedAsthmaUnited States
-
University of MonastirCompletedAtrial FibrillationTunisia