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

NCT02867137 | Completed DMC

• 1 other identifier: Protokol_v2_270616_PreTBI_I
• Study Type: observational
• Target: 595
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.Prehospital measurements of both GFAP and S100B results in lower false positive rates than in-hospital measurements.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• 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

  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

  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

  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

  in relation to event within 7 days of trauma

Other Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Mild TBI patients

Other: Blood sampling

Interventions

Blood sampling OTHER

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

Mild TBI patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (≥ 18 years) suffering isolated head trauma and receiving an ambulance dispatched by the prehospital emergency medical services in the Central Denmark Region.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead
• Central Denmark Region: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Prehospital Emergency Medical Services, Central Denmark Region

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Seidenfaden SC, Kjerulff JL, Juul N, Kirkegaard H, Moller MF, Munster AB, Botker MT. Diagnostic accuracy of prehospital serum S100B and GFAP in patients with mild traumatic brain injury: a prospective observational multicenter cohort study - "the PreTBI I study". Scand J Trauma Resusc Emerg Med. 2021 Jun 2;29(1):75. doi: 10.1186/s13049-021-00891-5.

  PMID: 34078435 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 15, 2016
• Study Start: February 15, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 24, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)