The PreTBI I study will investigate whether prehospital blood samples drawn already in the ambulance can rule-out intracranial lesions in patients suffering head trauma. The study aims to improve triage and treatment of patients suffering mild head trauma, who are considered low-risk patients. These patients do not always benefit from hospitalization, but are nevertheless admitted on precaution, as clinical assesment can be difficult. Hypotheses: 1. A prehospital measurement of serum S100B ≤ 0,10 microgram/L in mild TBI patients rules out traumatic intracranial lesion with a sensitivity \>97%. 2. A prehospital measurement of serum GFAP (glial acidic fibrillary protein) in mild TBI patients rules out traumatic intracranial lesion with sensitivity \>97% and results in lower false positive rate than S100B. 3. Prehospital measurements of both GFAP and S100B results in lower false positive rates than in-hospital measurements.
Study Type
OBSERVATIONAL
Enrollment
595
Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
Prehospital Emergency Medical Services, Central Denmark Region
Aarhus N, Denmark
Sensitivity of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
Intracranial lesion comprises abnormal CTC (Marshall Computed Tomography Classification) and/or neurosurgical observation/intervention being death \<7 days secondary to head injury or the need of following procedures: craniotomy, elevation of skull fracture, intracranial pressure monitoring or intubation for head injury. Abnormal CTC findings comprise any type of intracranial haemorrhage including subdural, epidural, subarachnoid, intracerebral haemorrhage, edema, pneumocephalus, cerebral contusion or skull cap/base fractures.
Time frame: in relation to event within 7 days of trauma
Specificity of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
Intracranial lesion comprises abnormal CTC (Marshall Computed Tomography Classification) and/or neurosurgical observation/intervention being death \<7 days secondary to head injury or the need of following procedures: craniotomy, elevation of skull fracture, intracranial pressure monitoring or intubation for head injury. Abnormal CTC findings comprise any type of intracranial haemorrhage including subdural, epidural, subarachnoid, intracerebral haemorrhage, edema, pneumocephalus, cerebral contusion or skull cap/base fractures.
Time frame: in relation to event within 7 days of trauma
Positive predictive value of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
Intracranial lesion comprises abnormal CTC (Marshall Computed Tomography Classification) and/or neurosurgical observation/intervention being death \<7 days secondary to head injury or the need of following procedures: craniotomy, elevation of skull fracture, intracranial pressure monitoring or intubation for head injury. Abnormal CTC findings comprise any type of intracranial haemorrhage including subdural, epidural, subarachnoid, intracerebral haemorrhage, edema, pneumocephalus, cerebral contusion or skull cap/base fractures.
Time frame: in relation to event within 7 days of trauma
Negative predictive value of se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
Intracranial lesion comprises abnormal CTC (Marshall Computed Tomography Classification) and/or neurosurgical observation/intervention being death \<7 days secondary to head injury or the need of following procedures: craniotomy, elevation of skull fracture, intracranial pressure monitoring or intubation for head injury. Abnormal CTC findings comprise any type of intracranial haemorrhage including subdural, epidural, subarachnoid, intracerebral haemorrhage, edema, pneumocephalus, cerebral contusion or skull cap/base fractures.
Time frame: in relation to event within 7 days of trauma
Sensitivity of se-GFAP in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
Intracranial lesion comprises abnormal CTC (Marshall Computed Tomography Classification) and/or neurosurgical observation/intervention being death \<7 days secondary to head injury or the need of following procedures: craniotomy, elevation of skull fracture, intracranial pressure monitoring or intubation for head injury. Abnormal CTC findings comprise any type of intracranial haemorrhage including subdural, epidural, subarachnoid, intracerebral haemorrhage, edema, pneumocephalus, cerebral contusion or skull cap/base fractures.
Time frame: in relation to event within 7 days of trauma
Specificity of se-GFAP in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
Intracranial lesion comprises abnormal CTC (Marshall Computed Tomography Classification) and/or neurosurgical observation/intervention being death \<7 days secondary to head injury or the need of following procedures: craniotomy, elevation of skull fracture, intracranial pressure monitoring or intubation for head injury. Abnormal CTC findings comprise any type of intracranial haemorrhage including subdural, epidural, subarachnoid, intracerebral haemorrhage, edema, pneumocephalus, cerebral contusion or skull cap/base fractures.
Time frame: in relation to event within 7 days of trauma
Positive predictive value of se-GFAP in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
Intracranial lesion comprises abnormal CTC (Marshall Computed Tomography Classification) and/or neurosurgical observation/intervention being death \<7 days secondary to head injury or the need of following procedures: craniotomy, elevation of skull fracture, intracranial pressure monitoring or intubation for head injury. Abnormal CTC findings comprise any type of intracranial haemorrhage including subdural, epidural, subarachnoid, intracerebral haemorrhage, edema, pneumocephalus, cerebral contusion or skull cap/base fractures.
Time frame: in relation to event within 7 days of trauma
Negative predictive value of se-GFAP in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no
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Intracranial lesion comprises abnormal CTC (Marshall Computed Tomography Classification) and/or neurosurgical observation/intervention being death \<7 days secondary to head injury or the need of following procedures: craniotomy, elevation of skull fracture, intracranial pressure monitoring or intubation for head injury. Abnormal CTC findings comprise any type of intracranial haemorrhage including subdural, epidural, subarachnoid, intracerebral haemorrhage, edema, pneumocephalus, cerebral contusion or skull cap/base fractures.
Time frame: in relation to event within 7 days of trauma