TbiNCT02351518
Cerebral Autoregulation and Vasospasm in Patients With TBI
An observational study of Tbi and Vasospasm, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tbi, Vasospasm, Cerebral Ischemia
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 15 years of age and greater
- Motor Glasgow Coma Score (GCS) < 6 within approximately 24 hours of admission
- Head AIS > 2
Who cannot join
- Motor GCS >5
- Determination of non-survivability on admission
- Non-English speakers
- Prisoners that are on parole or probation
- Active duty military
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
R Adams Cowley Shock Trauma Center, University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Cerebral Autoregulation and Vasospasm in Patients With Traumatic Brain Injury
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.
Read the detailed description
Primary Objectives: 1. To determine if impaired cerebral autoregulation as measured by NIRS is associated with clinically significant vasospasm in patients with moderate to severe TBI; 2. To determine the sensitivity and specificity of NIRS in detecting clinically significant vasospasm with Transcranial Doppler (TCD) ultrasound followed by CT brain angiography and diffusion-weighted brain MRI as the gold standard . Secondary Objectives: 1. To determine the relationship between impaired cerebral autoregulation and outcomes; 2. To determine the relationship between impaired cerebral autoregulation, clinically significant vasospasm and outcomes
Clinical observations The subject will be continuously monitored with INVOS NIRS system within the first 24 hours after admission up to 7 days while the subject is still in the STC. If decreased cerebral oxygenation is detected by NIRS, TCDs will be offered to the family and considered part of routine clinical care. If vasospasm is detected by TCD, CT brain angiography will be offered to the family for angiographic confirmation and considered part of routine clinical care. If vasospasm is confirmed by CT brain angiography, diffusion-weighted MRI will be offered to the family to evaluate for cerebral ischemia/infarction and considered part of routine clinical care.
Laboratory evaluations All patients will have at least twice daily measurements of serum electrolytes, blood counts, arterial blood gases, and coagulation profile as per our standard of care. Culture results will be recorded. No tests or procedure will be ordered for research purposes only.
Patient Management All enrolled patients will be admitted to the Neurotrauma Critical Care Unit (NTCC) and be jointly managed by the Trauma, Critical Care and Neurosurgical services. All patients will be managed utilizing the STC Institutional Severe Traumatic Brain Injury Management Algorithm which is based on the Brain Trauma Foundation Guidelines for the Management of Severe Traumatic Brain Injury. Other consults will be obtained as clinically indicated.
Questionnaires / Assessment tools Functional outcome using the Extended Glasgow Outcome Scale (GOS-E) will be assessed in the STC Outpatient Clinic as part of their standard of care. An early functional outcome assessment will be obtained if the GOS-E form is completed at the STC Outpatient Clinic within 6 weeks post hospital discharge day. A mid functional outcome assessment will be obtained if the GOS-E form is completed at the STC Outpatient Clinic 6 weeks to 3 months post hospital discharge day. A late functional outcome assessment will be obtained if the GOS-E form is completed at the STC Outpatient Clinic 3 months to 6 months post hospital discharge day. Finally, a very late functional outcome assessment will be obtained if the GOS-E form is completed at the STC Outpatient Clinic more than 6 months post-hospital discharge day.
STATISTICAL CONSIDERATIONS / ANALYSIS OF DATA The goal of this pilot study is to determine if impaired cerebral autoregulation as measured by NIRS is associated with the development of clinically significant vasospasm in patients with moderate to severe TBI. By enrolling 100 patients in the study, it is expected to estimate the correlation to within 0.098 with a probability of at least 95%. In this study, all primary and secondary outcomes may be classified into two categories: binary and continuous. In the first step, quantitative descriptive statistics will be used initially to study the characteristics of patients and the association between clinical outcomes (e.g. vasospasm) and various demographic and clinicopathologic variables such as age, gender and injury severity scores. For binary data, chi-square and Fisher's exact tests will be used to identify differences. For continuous variables, t-tests and analysis of variance (ANOVA) will be used to determine the significant association. These univariate tests will be done at a significance level of 0.05. In addition to constructing 95% confidence interval for the correlation of impaired cerebral autoregulation as measured by NIRS and clinically significant vasospasm, the investigators will also explore potential risk factors associated with impaired cerebral autoregulation and impaired cerebral autoregulation associated with vasospasm. To this end, the correlation will be analyzed using the logistic regression model with various demographic and clinicopathologic variables as independent variables. The stepwise regression procedure will be used for identifying potential risk factors for the incidence of vasospasm. To evaluate the validity of NIRs as an assessment method of vasospasm, the investigators will measure the agreement between TCD and NIRS by using kappa statistics.
- Conditions
- Tbi, Vasospasm, Cerebral Ischemia, Cerebral Infarct
- Being tested
- No intervention
- Medical subject headings
- Brain Injuries, Traumatic, Brain Ischemia, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There will be no interventions in this study
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Outcome as assessed by the Glasgow Functional Outcome-Extended
Measured: within 12 months post hospital discharge
Secondary outcomes (2)
Mortality
Measured: within 30 days
Hospital Length of Stay
Measured: within 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startNov 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TbiStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Stein, University of Maryland, Baltimore
- Investigators
- Deborah Stein, MD, MPH, Principal investigator, Professor of Surgery, Department of Surgery, Chief of Trauma R Adams Cowley Shock Trauma Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02351518
- Sponsor's protocol ID
- HP-00062723
- Status last verified
- Jan 2022
- First submitted
- 19 Jan 2015
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Autoregulation and Vasospasm in Patients With Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02351518
- Acronym / sponsor ID
- HP-00062723
- Conditions
- Tbi, Vasospasm, Cerebral Ischemia, Cerebral Infarct
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objectives: 1. To determine if impaired cerebral autoregulation as measured by NIRS is associated with clinically significant vasospasm in patients with moderate to severe TBI; 2. To determine the sensitivity and specificity of NIRS in detecting clinically significant vasospasm with Transcranial Doppler (TCD) ultrasound followed by CT brain angiography and diffusion-weighted brain MRI as the gold standard . Secondary Objectives: 1. To determine the relationship between impaired cerebral autoregulation and outcomes; 2. To determine the relationship between impaired cerebral autoregulation, clinically significant vasospasm and outcomes
Clinical observations The subject will be continuously monitored with INVOS NIRS system within the first 24 hours after admission up to 7 days while the subject is still in the STC. If decreased cerebral oxygenation is detected by NIRS, TCDs will be offered to the family and considered part of routine clinical care. If vasospasm is detected by TCD, CT brain angiography will be offered to the family for angiographic confirmation and considered part of routine clinical care. If vasospasm is confirmed by CT brain angiography, diffusion-weighted MRI will be offered to the family to evaluate for cerebral ischemia/infarction and considered part of routine clinical care.
Laboratory evaluations All patients will have at least twice daily measurements of serum electrolytes, blood counts, arterial blood gases, and coagulation profile as per our standard of care. Culture results will be recorded. No tests or procedure will be ordered for research purposes only.
Patient Management All enrolled patients will be admitted to the Neurotrauma Critical Care Unit (NTCC) and be jointly managed by the Trauma, Critical Care and Neurosurgical services. All patients will be managed utilizing the STC Institutional Severe Traumatic Brain Injury Management Algorithm which is based on the Brain Trauma Foundation Guidelines for the Management of Severe Traumatic Brain Injury. Other consults will be obtained as clinically indicated.
Questionnaires / Assessment tools Functional outcome using the Extended Glasgow Outcome Scale (GOS-E) will be assessed in the STC Outpatient Clinic as part of their standard of care. An early functional outcome assessment will be obtained if the GOS-E form is completed at the STC Outpatient Clinic within 6 weeks post hospital discharge day. A mid functional outcome assessment will be obtained if the GOS-E form is completed at the STC Outpatient Clinic 6 weeks to 3 months post hospital discharge day. A late functional outcome assessment will be obtained if the GOS-E form is completed at the STC Outpatient Clinic 3 months to 6 months post hospital discharge day. Finally, a very late functional outcome assessment will be obtained if the GOS-E form is completed at the STC Outpatient Clinic more than 6 months post-hospital discharge day.
STATISTICAL CONSIDERATIONS / ANALYSIS OF DATA The goal of this pilot study is to determine if impaired cerebral autoregulation as measured by NIRS is associated with the development of clinically significant vasospasm in patients with moderate to severe TBI. By enrolling 100 patients in the study, it is expected to estimate the correlation to within 0.098 with a probability of at least 95%. In this study, all primary and secondary outcomes may be classified into two categories: binary and continuous. In the first step, quantitative descriptive statistics will be used initially to study the characteristics of patients and the association between clinical outcomes (e.g. vasospasm) and various demographic and clinicopathologic variables such as age, gender and injury severity scores. For binary data, chi-square and Fisher's exact tests will be used to identify differences. For continuous variables, t-tests and analysis of variance (ANOVA) will be used to determine the significant association. These univariate tests will be done at a significance level of 0.05. In addition to constructing 95% confidence interval for the correlation of impaired cerebral autoregulation as measured by NIRS and clinically significant vasospasm, the investigators will also explore potential risk factors associated with impaired cerebral autoregulation and impaired cerebral autoregulation associated with vasospasm. To this end, the correlation will be analyzed using the logistic regression model with various demographic and clinicopathologic variables as independent variables. The stepwise regression procedure will be used for identifying potential risk factors for the incidence of vasospasm. To evaluate the validity of NIRs as an assessment method of vasospasm, the investigators will measure the agreement between TCD and NIRS by using kappa statistics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 15 years of age and greater
- Motor Glasgow Coma Score (GCS) < 6 within approximately 24 hours of admission
- Head AIS > 2
Key exclusion criteria (6 listed)
- Motor GCS >5
- Determination of non-survivability on admission
- Non-English speakers
- Prisoners that are on parole or probation
- Active duty military
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere will be no interventions in this study | Other | – |
Primary outcome
Functional Outcome as assessed by the Glasgow Functional Outcome-Extended
Time frame: within 12 months post hospital discharge
2 secondary outcomes
Mortality
Time frame: within 30 days
Hospital Length of Stay
Time frame: within 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Stein, MD, MPH principal investigator
Professor of Surgery, Department of Surgery, Chief of Trauma R Adams Cowley Shock Trauma Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tbi and Vasospasm, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Outcome as assessed by the Glasgow Functional Outcome-Extended (time frame: within 12 months post hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.