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Microvascular Injury and Blood-brain Barrier Dysfunction as Novel Biomarkers and Targets for Treatment in Traumatic Brain Injury

5. februar 2019 opdateret af: David Clarke, Nova Scotia Health Authority
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.

Studieoversigt

Status

Ukendt

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Forventet)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Rekruttering
        • Halifax Infirmary
        • Kontakt:
          • David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS
          • Telefonnummer: 902-473-4591
          • E-mail: d.clarke@dal.ca

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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).

Beskrivelse

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • 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
  • 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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in brain volume with blood brain barrier dysfunction
Tidsramme: 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
At < 4, 10 ± 2, and 90 ± 10 days post-injury
Change in serum biomarkers of blood brain barrier dysfunction
Tidsramme: 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)
At < 4, 10 ± 2, and 90 ± 10 days post-injury
Change in Glasgow Outcome Scale-Extended (GOS-E)
Tidsramme: 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.
At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
Change in Rivermead Post Concussion Symptom Questionnaire (RPSQ)
Tidsramme: 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.
At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
Change in Patient-Reported Outcomes Measurement Information System (PROMIS)
Tidsramme: 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.
At 10 ± 2 days, 90 ± 10 days, and 1 year post-injury
Change in post-traumatic epilepsy
Tidsramme: At 10 ± 2 days, 90 ± 10 days, 1 year, and 2 years post-injury
Screening for post-traumatic epilepsy
At 10 ± 2 days, 90 ± 10 days, 1 year, and 2 years post-injury

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nova Scotia Health Authority

Efterforskere

  • Ledende efterforsker: David B. Clarke, MD, PhD, Nova Scotia Health Authority

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. august 2017

Primær færdiggørelse (Forventet)

3. august 2019

Studieafslutning (Forventet)

3. august 2020

Datoer for studieregistrering

Først indsendt

26. april 2017

Først indsendt, der opfyldte QC-kriterier

1. maj 2017

Først opslået (Faktiske)

4. maj 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TMI_BBBD_2017

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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