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Trial record 35 of 292 for:    TBI | Recruiting, Not yet recruiting, Available Studies | "Brain Injuries, Traumatic"

Prognostic Potential of Prehospital Biomarkers in TBI Patients (PreTBI III)

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ClinicalTrials.gov Identifier: NCT03062566
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : May 4, 2018
Sponsor:
Collaborators:
Central Denmark Region
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

The PreTBI III study aims to investigate the prognostic potential of prehospital and repeated in-hospital S100B, NSE and GFAP measurements as predictors of neurological outcome in patients suffering severe TBI. Knowledge on prehospital S100B, GFAP and NSE levels as predictors of neurological outcome and mortality may underline the potential of a point-of-care analysis. Possibly, the early biomarker levels may contributed to accurate monitoring of biomarker dynamics and hereby support neurosurgeons and anaesthetists in the clinical decision-making regarding treatment and level of care offered to the patient.

Hypotheses:

  1. Prehospital S100B level is a significant predictor of unfavourable neurological outcome (dichotomized disability rating scale (DRS) and glasgow outcome scale extended (GOS-E) measures) in severe TBI patients.
  2. Prehospital GFAP level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
  3. Prehospital NSE level is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
  4. combined panel of prehospital S100B, GFAP and NSE levels is a significant predictor of unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients.
  5. Unfavourable neurological outcome (dichotomized DRS and GOSE measures) in severe TBI patients can be predicted by dynamics in repeated measurements of S100B, GFAP and NSE.

Condition or disease Intervention/treatment
Traumatic Brain INjury Other: Blood sampling

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Potential of Prehospital S100B, Glial Fibrillary Acidic Protein (GFAP) and Neuron Specific Annuals (NSE) Levels in Patients Suffering Severe Traumatic Brain Injury (TBI)
Actual Study Start Date : February 15, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Severe TBI patients
GCS 3-8
Other: Blood sampling
Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation




Primary Outcome Measures :
  1. Sensitivity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

  2. Specificity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

  3. Positive predictive value of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

  4. Negative predictive value of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)


Secondary Outcome Measures :
  1. Sensitivity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

  2. Specificity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

  3. Positive predictive value of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

  4. Negative predictive value of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

  5. Sensitivity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

  6. Specificity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

  7. Positive predictive value of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)

  8. Negative predictive value of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
    Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4)


Other Outcome Measures:
  1. Mortality rates corresponding to se-S100B values [ Time Frame: in relation to event within 1 year of trauma ]
    survival versus death <7 days, 3 months and 6 months after trauma 6-month

  2. Mortality rates corresponding to se-GFAP values [ Time Frame: in relation to event within 1 year of trauma ]
    survival versus death <7 days, 3 months and 6 months after trauma 6-month

  3. Mortality rates corresponding to se-NSE values [ Time Frame: in relation to event within 1 year of trauma ]
    survival versus death <7 days, 3 months and 6 months after trauma 6-month

  4. Sensitivity of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
  5. Specificity of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
  6. Positive predictive value of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
  7. Negative predictive value of combined se-S100B, se-GFAP and se-NSE in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
  8. Biomarker dynamics between prehospital and in-hospital se-S100B values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
  9. Biomarker dynamics between prehospital and in-hospital se-GFAP values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
  10. Biomarker dynamics between prehospital and in-hospital se-NSE values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]
  11. Biomarker dynamics between prehospital and in-hospital combination of se-S100B, se-GFAP and se-NSE values in relation to a binary outcome measured by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable [ Time Frame: in relation to event within 1 year of trauma ]

Biospecimen Retention:   Samples With DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance dispatched by the Prehospital Emergency Medical Services (EMS) in the Central Denmark Region.
Criteria

Inclusion Criteria:

  • Patients presenting with Glasgow Coma Score (GCS) GCS 3-8 suffering relevant trauma and displaying relevant clinical indices compatible with TBI as evaluated by EMS staff. Patients are considered incompetent due to on-going alteration of mental state.

Exclusion Criteria:

  • >6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) pathology.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062566


Contacts
Contact: Sophie-Charlott Seidenfadeb, MD 0045 2480 0706 soseid@rm.dk
Contact: Ingunn Skogstad Riddervold, Assistant Professor 0045 24759220 ingunn.riddervold@ph.rm.dk

Locations
Denmark
Prehospital Emergency Medical Services, Central Denmark Region Recruiting
Aarhus N, Denmark, 8200
Contact: Sophie-Charlott Seidenfaden, MD         
Contact: Ingunn S Riddervold, Ass. Professor         
Sponsors and Collaborators
University of Aarhus
Central Denmark Region
Aarhus University Hospital

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03062566     History of Changes
Other Study ID Numbers: Protokol_v3_240816_PreTBI_III
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Aarhus:
biomarkers
point-of-care analysis

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries