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Cerebral Autoregulation and Vasospasm in Patients With TBI

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ClinicalTrials.gov Identifier: NCT02351518
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Deborah Stein, University of Maryland

Brief 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 autoregulation as measured by near infrared spectroscopy (NIRS) with the development of clinically significant vasospasm in patients with moderate to severe TBI. The information will serve as preliminary data for further study.


Condition or disease Intervention/treatment
Tbi Vasospasm Cerebral Ischemia Cerebral Infarct Other: No intervention

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Autoregulation and Vasospasm in Patients With Traumatic Brain Injury
Study Start Date : November 2015
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Intervention Details:
  • Other: No intervention
    There will be no interventions in this study


Primary Outcome Measures :
  1. Functional Outcome as assessed by the Glasgow Functional Outcome-Extended [ Time Frame: within 12 months post hospital discharge ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: within 30 days ]
  2. Hospital Length of Stay [ Time Frame: within 60 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All patients aged 15 years and older, presenting with a motor score of <6 and thought to have TBI due to a mechanism of injury, will undergo screening with head computed tomography (CT). Admission CT will be interpreted by an attending radiologist to determine Head Abbreviated Injury Score (AIS) score. If the AIS score by CT is > 2, the patient will be eligible for the study. Patients determined by neurosurgery to have a non-survivable TBI on admission will be excluded given the poor likelihood of completion of the study protocol.
Criteria

Inclusion Criteria:

  • 15 years of age and greater
  • Motor Glasgow Coma Score (GCS) < 6 within approximately 24 hours of admission
  • Head AIS > 2

Exclusion Criteria:

  • Motor GCS >5
  • Determination of non-survivability on admission
  • Non-English speakers
  • Prisoners that are on parole or probation
  • Active duty military
  • Pregnant patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02351518


Locations
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United States, Maryland
R Adams Cowley Shock Trauma Center, University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
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Principal Investigator: Deborah Stein, MD, MPH Professor of Surgery, Department of Surgery, Chief of Trauma R Adams Cowley Shock Trauma Center

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Responsible Party: Deborah Stein, Professor, Department of Surgery, University of Maryland , Chief of Trauma R Adams Cowley Shock Trauma Center, University of Maryland
ClinicalTrials.gov Identifier: NCT02351518     History of Changes
Other Study ID Numbers: HP-00062723
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Brain Ischemia
Cerebral Infarction
Brain Diseases
Brain Infarction
Ischemia
Pathologic Processes
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Stroke