- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00505908
Non-Interventional F-Two Isoprostane Trial (NIFTI) (NIFTI)
Non-Interventional F-Two Isoprostane Trial
Each year in the United States alone, 300,000 persons are hospitalized for traumatic brain injury, with approximately one quarter dying. Despite advances in aggressive neurosurgical interventions, intensive care monitoring and overall supportive management, many of those who do "survive" do not fully recover and are left with a varying degree of permanent disability. It is therefore imperative that new methods of early interventions be explored.
One possible road to effective therapy is to examine the timing of secondary injury via a biological marker, to help guide the timing of treatment directed specifically at early oxidant injury. A more thorough understanding of how quickly oxidant injury occurs will allow us to direct appropriate therapies targeted directly at oxidant injury within what is currently thought to be a very narrow window of opportunity for intervention, possibly peaking within the first two hours after the initial injury.
Potential participants include patients between the ages of 18 and 50 years who are admitted to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury. Blood, urine, and CSF (if patient requires a clinically indicated ventriculostomy) will be collected over the first 5 days post-injury. Clinically-relevant patient progress, clinically required interventions, neuro-imaging results, and demographics will be tracked while the patient is hospitalized, with final neurological outcome measured at 3 months.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
Texas
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Dallas, Texas, Forenede Stater, 75235
- Parkland Memorial Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Estimated age of 18 - 50 years
- Glasgow Come Scale (GCS) score of between 3 and 8 prior to intubation and/or sedation.
- Systolic blood pressure of >90 mm Hg
- Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital, a Level I Trauma Center in Dallas, Texas
Exclusion Criteria:
- Those in whom the time of injury is unknown
- Those with any 2 readings of systolic blood pressure of <90 prior to enrollment
- Those who are known to have legal Do Not Resuscitate (DNR) orders in place prior to enrollment.
- Those receiving CPR prior to enrollment
- Known incarcerated individuals
- Pulse ox reading of < 90 prior to enrollment
- Status epilepticus prior to enrollment
- Penetrating head trauma
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Andet
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Levels of oxidant injury in cerebrospinal fluid following severe traumatic brain injury
Tidsramme: Up to 5 days
|
F2 Isoprostane levels in cerebrospinal fluid following severe traumatic brain injury
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Up to 5 days
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jane G Wigginton, M.D., University of Texas Southwestern Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 052007-034
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