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

Nuevos Biomarcadores y Tecnologia Para Una Mejores Reglas de predicción en el Traumatismo craneoncefálico Leve

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.

Study Overview

• Status: Recruiting
• Conditions: Mild Traumatic Brain Injury
• Intervention / Treatment: Other: Serum and saliva biomarkers

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Alfonso Lagares, MD, PhD; Phone Number: +34917792839; Email: alfonso.lagares@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre
    • Contact: Alfonso Lagares, MD, PhD; Phone Number: +34917792389; Email: alfonso.lagares@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

1000 participants suffering mild TBI

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MILD TBI Diagnostic and long term prognostic study; 1000 patients suffering mild Traumatic Brain Injury	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biomarkers diagnostic performance	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of GFAP and UCHL-1, S100B, Osteopontin, SAA1, YKL-40, Copeptin, NSE, C reactive protein, procalcitonin to detect the presence or absence of intracranial lesions on CT scan	24 hours after mild TBI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the potential of the biomarkers in predicting neurological symptoms after TBI	Early and midterm biomarker predictive performance in terms of predicting neurological outcome. Neurological status at 1 week, 3 months, 6 months and 1 year after TBI and Rivermead post concussion questionnaire.	1 week, 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI	Early, midterm and long term biomarker predictive performance in terms of predicting neurological outcome. Extended Glasgow Outcome Score (GOSE)	1 week, 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI	Early, midterm and longterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by Qolibri-OS	1 week, 3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI	Mid and longterm biomarker predictive performance in terms of predicting quality of life after mild TBI assessed by EQ-5D-5L	3 months, 6 months and 1 year
Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales	Mid and longterm biomarker predictive performance in terms of quality of sleep	3 months, 6 months and 1 year

Collaborators and Investigators

• Sponsor: Hospital Universitario 12 de Octubre

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2022
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 21/709

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No