Biomarkers in Prehospital Prediction of Need for Neurosurgical Observation or Intervention in TBI Patients

NCT03028376 | Completed DMC

• 1 other identifier: Protokol_v3_240816_PreTBI_II
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The PreTBI II study aims to investigate the diagnostic potential of prehospital S100B and GFAP measurements in prediction of need for neurosurgical observation and/or intervention in moderate TBI patients, to rule-in high-risk patients. Ultimately to select patients who will benefit from neuro surgical expertise in specialized departments and thereby possibly better patient outcome. Hopefully also minimize treatment delay, secure optimal resource consumption and streamline patient courses by predicting the presence of neurotrauma. Hypotheses:

1. 1.A prehospital serum S100B level \> 0,10 microgram/L and expectedly above a certain and currently unknown cut-off value indicates the need for neurosurgical observation and/or intervention in moderate TBI patients.
2. 2.A prehospital serum GFAP level above a certain and currently unknown cut-off value can significantly predict a need for urgent neurosurgical observation and/or intervention in moderate TBI patients.
3. 3.Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict a need for urgent neurosurgical observation and/or intervention.
4. 4.Biomarker dynamics between prehospital and in-hospital biomarker values of S100B and GFAP can significantly predict hospital course and outcome of patients with moderate TBI.

Conditions

Traumatic Brain INjury

Keywords

biomarker; point-of-care analysis

Outcome Measures

Primary Outcomes (4)

• Sensitivity of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no

  in relation to event within 7 days of trauma

• Specificity of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no

  in relation to event within 7 days of trauma

• Positive predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no

  in relation to event within 7 days of trauma

• Negative predictive value of se-S100B in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no

  in relation to event within 7 days of trauma

Secondary Outcomes (4)

• Sensitivity of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no

  in relation to event within 7 days of trauma

• Specificity of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no

  in relation to event within 7 days of trauma

• Positive predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no

  in relation to event within 7 days of trauma

• Negative predictive value of se-GFAP in relation to a binary outcome measured by a yes/no question of "need for neurosurgical observation and/or intervention" pick yes/no

  in relation to event within 7 days of trauma

Other Outcomes (9)

• Sensitivity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred

  in relation to event within 24 hours of trauma

• Specificity of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred

  in relation to event within 24 hours of trauma

• Positive predictive value of combined se-S100B and se-GFAP in relation to a binary outcome measured by by a yes/no question of "immediate treatment <24h/deferred treatment <24h" pick immediate/deferred

  in relation to event within 24 hours of trauma

Study Arms (1)

Moderate TBI patients

GCS 9-13

Other: Blood sampling

Interventions

Blood sampling OTHER

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

Moderate 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

All adult patients (≥18 years) suffering isolated head trauma and receiving an ambulance or anaesthetist-staffed critical care team dispatched by the Prehospital Emergency Medical Services (EMS) in the Central Denmark Region.

You may qualify if:

• Patients presenting with Glasgow Coma Score (GCS) GCS 9-13 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.

You may not qualify if:

• Patients \<18 years, GCS \<9, \>6 hours elapsed after trauma, unknown time of trauma, multi trauma, known dementia, chronic psychosis or active central nervous system (CNS) 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

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: November 21, 2016
• First Posted: January 23, 2017
• Study Start: February 15, 2017
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 24, 2019

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)