Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004730
Status:
COMPLETED
Last Update Posted:
2011-10-28
First Post:
2000-02-25
Brief Title:
Magnesium Sulfate For Brain Injury
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Magnesium Sulfate for Neuroprotection After Brain Trauma
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 sulfates 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 1meqkg given intravenously within 8 hours of injury Then a five day continuous intravenous infusion of magnesium sulfate 024meqkg per hour is begun Daily magnesium levels are checked and the dose changed in order to keep the Magnesium blood level at approximately 4meqL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None