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NCT02351518 · ClinicalTrials.gov registry record
Cerebral Autoregulation and Vasospasm in Patients With TBI
A clinical trial of TBI and Cerebral Ischemia, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- 25
- Enrollment target
- 1
- Study location
NCT02351518 is a study of TBI and Cerebral Ischemia that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 25 participants, below the 1,503-participant average among 7 other TBI trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02351518, a study of TBI and Cerebral Ischemia, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Traumatic brain injury (TBI) affects 1.5 million patients per year in the United States, resulting in more than 50,000 deaths and more than 230,000 hospitalizations annually. Approximately 90,000 of these patients will suffer permanent impairment and more than half will experience short-term disability. Secondary injury processes play a critical role in the development of ischemia after trauma to the central nervous system and occur hours-to-days after the primary insult. Ischemia can lead to cerebral infarction or stroke. Ischemia has been described as the single most important secondary insult and has been identified histologically in approximately 90% of patients who die following closed head injury. Several factors resulting in post-traumatic cerebral ischemia have been identified: increased intracranial pressure (ICP), systemic arterial hypotension, and cerebral vasospasm. Cerebral vasospasm has been described as a sustained arterial narrowing. Clinically, the onset of new or worsening neurological symptoms is the most reliable indicator of cerebral vasospasm following a ruptured cerebral aneurysm. However, cerebral vasospasm is often unrecognized in patients suffering from moderate to severe TBI. These patients frequently have altered mental status due to the primary brain injury. In addition, they require narcotics for their pain and paralytics and/or sedatives while on a mechanical ventilator for airway protection. Thus, relying on the neurological exam to observe deteriorating neurological signs consistent with post-traumatic vasospasm (PTV) is reliable. While the etiology and outcome of patients with vasospasm secondary to ruptured aneurysm is well documented, the clinical significance of PTV after TBI is unknown. A better understanding of the role of cerebral autoregulation in the development of cerebral vasospasm could provide the answer. This proposal is for a pilot observational study describing the association of the impairment of cerebral autoregula
Conditions Studied
Interventions
- OTHER No intervention
Study Locations (1)
Maryland
- R Adams Cowley Shock Trauma Center, University of Maryland Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-06-30 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02351518
The ClinicalTrials.gov registry entry for NCT02351518 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,503-participant average among 7 other TBI trials with a reported enrollment target (98% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with TBI appearing as the primary indexed condition, and to 1 intervention - of which No intervention is the first listed.
NCT02351518 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT02351518 about?
NCT02351518 is a clinical study titled "Cerebral Autoregulation and Vasospasm in Patients With TBI". Traumatic brain injury (TBI) affects 1.5 million patients per year in the United States, resulting in more than 50,000 deaths and more than 230,000 hospitalizations annually. Approximately 90,000 of these patients will suffer permanent impairment and more than half will experience short-term disabil...
What is the current status of trial NCT02351518?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2015-11. Estimated completion is 2017-06-30.
What conditions does trial NCT02351518 study?
This clinical trial studies the following conditions: TBI, Cerebral Ischemia, Vasospasm, Cerebral Infarct.
What interventions are being tested in trial NCT02351518?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT02351518?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02351518 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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