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| Name | Class |
|---|---|
| Central Denmark Region | OTHER |
| Aarhus University Hospital | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe TBI patients | GCS 3-8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year |
| Specificity of se-S100B in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year |
| 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 | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year |
| 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 | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rates corresponding to se-S100B values | survival versus death <7 days, 3 months and 6 months after trauma 6-month | in relation to event within 1 year of trauma |
| Mortality rates corresponding to se-GFAP values |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prehospital Emergency Medical Services, Central Denmark Region | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Blood samples
| Specificity of se-GFAP in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable |
Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) |
| in relation to event within 1 year of trauma |
| 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 | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year of trauma |
| 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 | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year of trauma |
| Sensitivity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year of trauma |
| Specificity of se-NSE in relation to a binary outcome measured by by a yes/no question of "favorable neurological outcome" pick favorable/unfavorable | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year of trauma |
| 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 | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year of trauma |
| 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 | Neurological outcome will be evaluated by a dichotomized glasgow outcome score extended (GOSE) as "Favorable (GOSE 5-8)/Unfavorable (GOSE 1-4) | in relation to event within 1 year of trauma |
survival versus death <7 days, 3 months and 6 months after trauma 6-month
| in relation to event within 1 year of trauma |
| Mortality rates corresponding to se-NSE values | survival versus death <7 days, 3 months and 6 months after trauma 6-month | in relation to event within 1 year of trauma |
| 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 | in relation to event within 1 year of trauma |
| 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 | in relation to event within 1 year of trauma |
| 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 | in relation to event within 1 year of trauma |
| 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 | in relation to event within 1 year of trauma |
| 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 | in relation to event within 1 year of trauma |
| 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 | in relation to event within 1 year of trauma |
| 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 | in relation to event within 1 year of trauma |
| 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 | in relation to event within 1 year of trauma |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |