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

Mild Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06327776
• Other study ID #: 21/709
• Status: Recruiting
• Start date: March 4, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Hospital Universitario 12 de Octubre
• Contact: Alfonso Lagares, MD, PhD
• Phone: +34917792839
• Email: alfonso.lagares[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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