Cerebral Autoregulation and Vasospasm in Patients With TBI

NCT02351518 | Completed

• 1 other identifier: HP-00062723
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Tbi; Vasospasm; Cerebral Ischemia; Cerebral Infarct

Outcome Measures

Primary Outcomes (1)

• Functional Outcome as assessed by the Glasgow Functional Outcome-Extended

  within 12 months post hospital discharge

Secondary Outcomes (2)

• Mortality

  within 30 days

• Hospital Length of Stay

  within 60 days

Interventions

No intervention OTHER

There will be no interventions in this study

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

R Adams Cowley Shock Trauma Center, University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Ischemia; Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Stroke; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Deborah Stein, MD, MPH

  Professor of Surgery, Department of Surgery, Chief of Trauma R Adams Cowley Shock Trauma Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Surgery, University of Maryland , Chief of Trauma R Adams Cowley Shock Trauma Center

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 30, 2015
• Study Start: November 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: January 27, 2022

Record last verified: 2022-01

Locations

US (1)