Traumatic Brain InjuryNCT03139682
Microvascular Injury and Blood-brain Barrier Dysfunction as Novel Biomarkers and Targets for Treatment in Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Blood Brain Barrier Defect, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Traumatic brain injury (TBI) is a leading cause of death and disability around the world. The social and economic burden of TBI is tremendous and the cost of TBI is estimated at $1 billion per year in Canada- $650 million in care and $580 million in lost productivity. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Traumatic Brain Injury, Blood Brain Barrier Defect
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 3 Aug 2017to 3 Aug 2021
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit mild (n=40), moderate (n=40) and severe (n=40) TBI patients with a TBI-linked abnormality (e.g. epidural \& subdural hematomas, subarachnoid hemorrhage, contusions). TBI will be classified by severity using the Glasgow Coma Scale (GCS); mild TBI (GCS13-15), moderate TBI (GCS 9-12), and severe TBI (GCS <8).
Who may be able to join
- Age 18 - 85 inclusive
- Clinically diagnosed TBI or evidence of TBI
- For mild TBI, as defined by the American Congress on Rehabilitation Medicine (1993), clear evidence and/or documentation of blunt head injury and any one of the following:
- any loss of consciousness up to 30 min
- any loss of memory for events immediately before or after the injury as much as 24 h
- any alteration of mental state at the time of the injury
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- focal neurologic deficits that might or might not be transient
- but where the severity of the injury does not exceed oss of consciousness exceeding 30 min, posttraumatic amnesia longer than 24 h, a Glasgow Coma Scale score falling below 13 after 30 min.
- For moderate TBI (GCS 9-12) and severe TBI (GCS 4-8) CT evidence of TBI-linked abnormality (intracranial lesion including traumatic SAH, contusion, extra-axial hematoma). For patients who are intubated, use best documented GCS within first 48 hours of injury.
- Stable respiratory or hemodynamic status allowing MRI within 2-4 days of TBI as determined by the attending physician
- Patient or substitute decision maker can provide consent
Who cannot join
- Pre-existing known neurologic, psychiatric disease (dementia, prior severe TBI, schizophrenia, uncontrolled epilepsy, major depressive disorder, stroke, multiple sclerosis, brain tumor)
- Serious infection, complications (sepsis, multilobe pneumonia, etc.) < 4 days after TBI
- Acute ischemic heart disease (MI or unstable angina)
- SBP < 100 mm Hg, DBP < 60 mm Hg
- MRI contraindications; patient has metal implant, pacemaker, biostimulator, neurostimulator, internal defibrillator, history of metal in eye, inner ear implant, cerebral aneurism clip, joint replacement, any known metal in their body, or are pregnant or breast feeding
- History or evidence of active malignancy
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- History or evidence of serious kidney (GFR =<60) , heart, or liver disease
- Pregnant or breast-feeding women
- Inability to complete follow up visits (e.g. tourists)
Trial locations and contacts
1 site in 1 country.
About this study
Traumatic brain injury (TBI) is a leading cause of death and disability around the world. The social and economic burden of TBI is tremendous and the cost of TBI is estimated at $1 billion per year in Canada- $650 million in care and $580 million in lost productivity. Novel interventions aimed at TBI-linked molecular targets have been successful in limiting injury and improving neurologic recovery in animal models, thus providing compelling evidence that effective intervention is possible after injury. This study proposes to investigate traumatic microvascular injury (TMI) and specifically blood-brain barrier dysfunction (BBBD) as a candidate biomarker and therapeutic target in TBI.
- Conditions
- Traumatic Brain Injury, Blood Brain Barrier Defect
- Medical subject headings
- Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain volume with blood brain barrier dysfunction
Measurement of change in brain volume with BBBD and extent of permeability change as measured by DCE-MRI
Measured: At < 4, 10 ± 2, and 90 ± 10 days post-injury
Change in serum biomarkers of blood brain barrier dysfunction
Measurement of change in serum biomarkers of BBBD / neural injury (vWF, BDNF, GFAP, S100β, sTau, and sNFL)
Measured: At < 4, 10 ± 2, and 90 ± 10 days post-injury
Change in Glasgow Outcome Scale-Extended (GOS-E)
The GOS-E is intended to provide a general index of overall outcome that is sensitive to small but clinically relevant treatment effects in people who sustain TBI.
Measured: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
Change in Rivermead Post Concussion Symptom Questionnaire (RPSQ)
The RPSQ is a 16-item self-report measure administered to individual(s) who sustained a TBI in order to measure the severity of symptoms and assess progress.
Measured: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS is a set of person-centered measures that evaluates and monitors domains such as physical, mental and social health in adults and children. For this study, we will utilize the following domains: depression, fatigue, and pain interference.
Measured: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
Change in post-traumatic epilepsy
Screening for post-traumatic epilepsy
Measured: At 10 ± 2 days, 90 ± 10 days, 1 year, and 2 years post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start3 Aug 2017
- Primary completion3 Aug 2019
- Study completion3 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David B. Clarke, MD, PhD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139682
- Sponsor's protocol ID
- TMI_BBBD_2017
- Status last verified
- Jan 2023
- First submitted
- 26 Apr 2017
- Last updated
- 2 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Injury and Blood-brain Barrier Dysfunction as Novel Biomarkers and Targets for Treatment in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03139682
- Acronym / sponsor ID
- TMI_BBBD_2017
- Conditions
- Traumatic Brain Injury, Blood Brain Barrier Defect
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 3 Aug 2017 (actual)
- Primary completion
- 3 Aug 2019 (actual)
- Study completion
- 3 Aug 2021 (actual)
- First posted
- 4 May 2017 (actual)
- 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) is a leading cause of death and disability around the world. The social and economic burden of TBI is tremendous and the cost of TBI is estimated at $1 billion per year in Canada- $650 million in care and $580 million in lost productivity. Novel interventions aimed at TBI-linked molecular targets have been successful in limiting injury and improving neurologic recovery in animal models, thus providing compelling evidence that effective intervention is possible after injury. This study proposes to investigate traumatic microvascular injury (TMI) and specifically blood-brain barrier dysfunction (BBBD) as a candidate biomarker and therapeutic target in TBI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit mild (n=40), moderate (n=40) and severe (n=40) TBI patients with a TBI-linked abnormality (e.g. epidural \& subdural hematomas, subarachnoid hemorrhage, contusions). TBI will be classified by severity using the Glasgow Coma Scale (GCS); mild TBI (GCS13-15), moderate TBI (GCS 9-12), and severe TBI (GCS <8).
Key inclusion criteria (11 listed)
- Age 18 - 85 inclusive
- Clinically diagnosed TBI or evidence of TBI
- For mild TBI, as defined by the American Congress on Rehabilitation Medicine (1993), clear evidence and/or documentation of blunt head injury and any one of the following:
- but where the severity of the injury does not exceed oss of consciousness exceeding 30 min, posttraumatic amnesia longer than 24 h, a Glasgow Coma Scale score falling below 13 after 30 min.
- For moderate TBI (GCS 9-12) and severe TBI (GCS 4-8) CT evidence of TBI-linked abnormality (intracranial lesion including traumatic SAH, contusion, extra-axial hematoma). For patients who are intubated, use best documented GCS within first 48 hours of injury.
Key exclusion criteria (9 listed)
- Pre-existing known neurologic, psychiatric disease (dementia, prior severe TBI, schizophrenia, uncontrolled epilepsy, major depressive disorder, stroke, multiple sclerosis, brain tumor)
- Serious infection, complications (sepsis, multilobe pneumonia, etc.) < 4 days after TBI
- Acute ischemic heart disease (MI or unstable angina)
- SBP < 100 mm Hg, DBP < 60 mm Hg
- MRI contraindications; patient has metal implant, pacemaker, biostimulator, neurostimulator, internal defibrillator, history of metal in eye, inner ear implant, cerebral aneurism clip, joint replacement, any known metal in their body, or are pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in brain volume with blood brain barrier dysfunction
Time frame: At < 4, 10 ± 2, and 90 ± 10 days post-injury
Measurement of change in brain volume with BBBD and extent of permeability change as measured by DCE-MRI
Change in serum biomarkers of blood brain barrier dysfunction
Time frame: At < 4, 10 ± 2, and 90 ± 10 days post-injury
Measurement of change in serum biomarkers of BBBD / neural injury (vWF, BDNF, GFAP, S100β, sTau, and sNFL)
Change in Glasgow Outcome Scale-Extended (GOS-E)
Time frame: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
The GOS-E is intended to provide a general index of overall outcome that is sensitive to small but clinically relevant treatment effects in people who sustain TBI.
Change in Rivermead Post Concussion Symptom Questionnaire (RPSQ)
Time frame: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
The RPSQ is a 16-item self-report measure administered to individual(s) who sustained a TBI in order to measure the severity of symptoms and assess progress.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
PROMIS is a set of person-centered measures that evaluates and monitors domains such as physical, mental and social health in adults and children. For this study, we will utilize the following domains: depression, fatigue, and pain interference.
Change in post-traumatic epilepsy
Time frame: At 10 ± 2 days, 90 ± 10 days, 1 year, and 2 years post-injury
Screening for post-traumatic epilepsy
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 2 Feb 2023.
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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.
David B. Clarke, MD, PhD principal investigator
Nova Scotia Health Authority
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 Traumatic Brain Injury and Blood Brain Barrier Defect, run by Nova Scotia Health Authority at 1 site in Canada.
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 11 inclusion and 9 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 2 Feb 2023. 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 Canada. 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?
Change in brain volume with blood brain barrier dysfunction (time frame: At < 4, 10 ± 2, and 90 ± 10 days post-injury). The study lists 6 primary outcomes in all. 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 2 Feb 2023.