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NCT01333488 · ClinicalTrials.gov registry record · Phase 2
Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
A Phase 2 study, sponsored by United States Department of Defense.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT01333488 is a Phase 2 study that was terminated before completion, run by United States Department of Defense. The registered enrollment target is 6 participants.
The verdict
NCT01333488, a Phase 2 study, was terminated before completion, sponsored by United States Department of Defense.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
The investigators hypothesize that hypothermia (body cooling) and additional magnesium sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients. This is a study to compare the outcomes of patients with severe traumatic brain injury who have been allocated to one of the following three groups: Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have their core body temperature lowered to 34C Group 3 - Subjects will have their core body temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium sulfate.
Interventions
- DRUG Magnesium Sulfate
- DEVICE Arctic Sun
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01333488
The ClinicalTrials.gov registry entry for NCT01333488 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Department of Defense, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Magnesium Sulfate is the first listed.
NCT01333488 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01333488 about?
NCT01333488 is a clinical study titled "Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects". The investigators hypothesize that hypothermia (body cooling) and additional magnesium sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients. This is a study to compare the outcomes of patients with severe traumatic brain injury who have been allocated to one of the follo...
What is the current status of trial NCT01333488?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2011-12. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01333488?
The interventions under investigation include: Magnesium Sulfate (DRUG), Arctic Sun (DEVICE).
Who is sponsoring clinical trial NCT01333488?
This trial is sponsored by United States Department of Defense, which has 13 total clinical trials registered on ClinicalTrials.gov.
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