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NCT00974259 · ClinicalTrials.gov registry record · Phase 2
Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (TBI)
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
NCT00974259: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT00974259 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 122 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00974259, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
Study Summary
Traumatic brain injury (TBI) is a major cause of death and disability, with an estimated cost of 45 billion dollars a year in the United States alone. Every year, approximately 1.4 million sustain a TBI, of which 50,000 people die, and another 235,000 are hospitalized and survive the injury. As a result, 80,000-90,000 people experience permanent disability associated with TBI. This project is designed to determine whether a device designed to measure brain tissue oxygenation and thus detect brain ischemia while it is still potentially treatable shows promise in reducing the duration of brain ischemia, and to obtain information required to conduct a definitive clinical trial of efficacy. A recently approved device makes it feasible to directly and continuously monitor the partial pressure of oxygen in brain tissue (pBrO2). Several observational studies indicate that episodes of low pBrO2 are common and are associated with a poor outcome, and that medical interventions are effective in improving pBrO2 in clinical practice. However, as there have been no randomized controlled trials carried out to determine whether pBrO2 monitoring results in improved outcome after severe TBI, use of this technology has not so far been widely adopted in neurosurgical intensive care units (ICUs). This study is the first randomized, controlled clinical trial of pBrO2 monitoring, and is designed to obtain data required for a definitive phase III study, such as efficacy of physiologic maneuvers aimed at treating pBrO2, and feasibility of standardizing a complex intensive care unit management protocol across multiple clinical sites. Patients with severe TBI will be monitored with Intracranial pressure monitoring (ICP) and pBrO2 monitoring, and will be randomized to therapy based on ICP along (control group) or therapy based on ICP in addition to pBrO2 values (treatment group). 182 participants will be enrolled at four clinical sites, the University of Texas Southwestern Medical Center/Par
Interventions
- DEVICE Management protocol based on pBrO2 and ICP values.
- DEVICE Management protocol based on ICP values only.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2009-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00974259
The ClinicalTrials.gov registry entry for NCT00974259 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Management protocol based on pBrO2 and ICP values. is the first listed.
NCT00974259 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00974259 about?
NCT00974259 is a clinical study titled "Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (TBI)". Traumatic brain injury (TBI) is a major cause of death and disability, with an estimated cost of 45 billion dollars a year in the United States alone. Every year, approximately 1.4 million sustain a TBI, of which 50,000 people die, and another 235,000 are hospitalized and survive the injury. As a re...
What is the current status of trial NCT00974259?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2009-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00974259?
The interventions under investigation include: Management protocol based on pBrO2 and ICP values. (DEVICE), Management protocol based on ICP values only. (DEVICE).
Who is sponsoring clinical trial NCT00974259?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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