NCT06327776

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 25, 2024

Status Verified

October 1, 2023

Enrollment Period

3.4 years

First QC Date

March 18, 2024

Last Update Submit

March 18, 2024

Conditions

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Determination of the potential of the biomarkers in predicting neurological symptoms after TBI

    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

    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

    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

    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

    3 months, 6 months and 1 year

Study Arms (1)

MILD TBI Diagnostic and long term prognostic study

1000 patients suffering mild Traumatic Brain Injury

Other: Serum and saliva biomarkers

Interventions

Serum and saliva biomarkersOTHER

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.

MILD TBI Diagnostic and long term prognostic study

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1000 participants suffering mild TBI

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, saliva

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Central Study Contacts

Alfonso Lagares, MD, PhD

CONTACT

+34917792839alfonso.lagares@salud.madrid.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 25, 2024

Study Start

March 4, 2022

Primary Completion

July 31, 2025

Study Completion

December 31, 2025

Last Updated

March 25, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)