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

NCT ID: NCT06327776

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-04

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Traumatic Brain Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MILD TBI Diagnostic and long term prognostic study

1000 patients suffering mild Traumatic Brain Injury

Serum and saliva biomarkers

Intervention Type OTHER

2x5mL blood samples and saliva samples will be used to determine the performance of different blood based and saliva biomarkers for determining diagnostic management and prognosis in mTBI patients.

Interventions

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Serum and saliva biomarkers

2x5mL blood samples and saliva samples will be used to determine the performance of different blood based and saliva biomarkers for determining diagnostic management and prognosis in mTBI patients.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario 12 de Octubre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Alfonso Lagares, MD, PhD

Role: CONTACT

+34917792839

Facility Contacts

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Alfonso Lagares, MD, PhD

Role: primary

+34917792389

Other Identifiers

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21/709

Identifier Type: -

Identifier Source: org_study_id

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