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BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)

NCT04641767 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2022-02-22

No results posted yet for this study

Summary

Traumatic brain injury (TBI) is defined as a structural alteration of brain function caused by external causes, where mild traumatic brain injury (mTBI) represents approximately 80% of all TBI, and although its prognosis is relatively good, it represents a significant cost to the system due to the need to perform a cranial computed tomography (CT) scan, a test of high economic value and not without risks such as irradiation, especially important and dangerous in the pediatric age.

The investigators aim to set-up a point of-care (POC) device to validate a biomarker (H-FABP) able to diagnose the presence of brain damage in children and adults with mTBI at trauma and paediatric Emergency Departments using a blood sample, in order to save resources and avoid subjecting patients to a potentially damaging imaging test. But also, to assess whether the incorporation of new biomarkers improves the prediction of brain damage that can be done with H-FABP.

For that, the investigators will recruit a 400 patients' cohort with blood samples using the available POC device for H-FABP biomarker.

Conditions

  • Mild Traumatic Brain Injury
  • Moderate Traumatic Brain Injury

Sponsors & Collaborators

  • Hospitales Universitarios Virgen del Rocío

    collaborator OTHER

  • Germans Trias i Pujol Hospital

    collaborator OTHER

  • Hospital Sant Joan de Deu

    collaborator OTHER

  • Hospital Universitario La Paz

    collaborator OTHER

  • Hospital Infantil Universitario Niño Jesús, Madrid, Spain

    collaborator OTHER

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Complejo Hospitalario La Mancha Centro

    collaborator OTHER

  • Hospital Son Espases

    collaborator OTHER

  • Hospital Miguel Servet

    collaborator OTHER

  • Hospital Universitario Virgen Macarena

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-28
Primary Completion
2022-02-14
Completion
2022-02-21

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04641767 on ClinicalTrials.gov