Biomarkers in Prehospital Rule-out of Intracranial Lesions in TBI Patients

Traumatic Brain Injury Clinical Trial

— PreTBI I  

Official title:

Diagnostic Potential of S100B and GFAP in Prehospital Rule-out of Intracranial Lesions in Patients Suffering Mild Traumatic Brain Injury (TBI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867137
• Other study ID #: Protokol_v2_270616_PreTBI_I
• Status: Completed
• Start date: February 15, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 595
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients presenting with Glasgow Coma Score (GCS) =13-15 and a loss of consciousness for less than 30 min and/or alteration of mental state (being dazed, confused or disorientated) and/or loss of memory for events immediately before and/or after the trauma. The emergency medical service staff will be guided through the inclusion and consent procedures by a simple tablet algorithm.

Exclusion Criteria:

• Patients <18 years, GCS <13, >6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system pathology.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Other:
• Blood sampling
Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation

Locations

Country	Name	City	State
Denmark	Prehospital Emergency Medical Services, Central Denmark Region	Aarhus N

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital, Central Denmark Region

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarker dynamics between prehospital and in-hospital se-S100B in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no		in relation to event within 7 days of trauma
Other	Biomarker dynamics between prehospital and in-hospital se-GFAP in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no		in relation to event within 7 days of trauma
Other	Biomarker dynamics between prehospital and in-hospital combination of se-S100B andse-GFAP values in relation to a binary outcome of clinical patient outcome measured by a yes/no question of "intracranial lesion" pick yes/no		in relation to event within 7 days of trauma
Primary	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.	in relation to event within 7 days of trauma
Primary	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.	in relation to event within 7 days of trauma
Primary	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.	in relation to event within 7 days of trauma
Primary	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.	in relation to event within 7 days of trauma
Secondary	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.	in relation to event within 7 days of trauma
Secondary	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.	in relation to event within 7 days of trauma
Secondary	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.	in relation to event within 7 days of trauma
Secondary	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	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.	in relation to event within 7 days of trauma