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New Protein Biomarkers and Technology for Improving Diagnosis and Outcome Prediction in Mild TBI

M

Madrid Health Service

Status

Enrolling

Conditions

Mild Traumatic Brain Injury

Treatments

Other: Serum and saliva biomarkers

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities.

Enrollment

1,000 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Mild TBI (GCS 13-15 on admission)
  • Blood sample obtained ≤24h after injury

Exclusion criteria

  • GCS 3-12 on admission
  • Time of injury unknown
  • Time to injury exceeding 24 hours
  • Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)
  • Penetrating head trauma
  • Patient with mechanical ventilation from the trauma scene or prehospital management.
  • Venipuncture not feasible
  • Subject under judiciary control

Trial design

1,000 participants in 1 patient group

MILD TBI Diagnostic and long term prognostic study
Description:
1000 patients suffering mild Traumatic Brain Injury
Treatment:
Other: Serum and saliva biomarkers

Trial contacts and locations

1

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Central trial contact

Alfonso Lagares, MD, PhD

Data sourced from clinicaltrials.gov

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