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NCT07311486: IMPACTS-BRAINI
Implementation of Biomarker-Based Care for mTBI - IMPACTS-BRAINI Study
trial testing GFAP and UCH-L1 in Mild Traumatic Brain Injury (mTBI) in 1,000 participants. Currently enrolling.
1 May 2026
Quick facts
| Lead sponsor | Hospital Universitario 12 de Octubre |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 15 July 2025 |
| Primary completion | 1 May 2026 |
| Estimated completion | 1 May 2026 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- GFAP and UCH-L1
Conditions studied
- Mild Traumatic Brain Injury (mTBI) — all drugs for Mild Traumatic Brain Injury (mTBI) →
Sponsor
Hospital Universitario 12 de Octubre
Who can join
18 and older, any sex, with Mild Traumatic Brain Injury (mTBI). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study aims to evaluate the real-world applicability and clinical added value of a new management pathway for patients presenting to the emergency department (ER) with mild traumatic brain injury (mTBI). The pathway includes the use of the VIDAS® TBI in vitro diagnostic assay, which measures the blood biomarkers GFAP and UCH-L1 within 12 hours of injury to determine whether a CT scan is necessary. The study seeks to answer two primary questions: 1. Safety and effectiveness: Whether the VIDAS® TBI test can safely and accurately rule out the need for head CT in mTBI patients in routine emergency care. 2. Clinical and operational impact: Whether incorporating this test reduces the number of CT scans performed and shortens ER length of stay for patients with mild TBI. To assess these outcomes, researchers will compare patient management using the new biomarker-based pathway to a historical cohort of mTBI patients who were managed without the biomarker test.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07311486
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GFAP and UCH-L1
Trials testing the same drug.
- NCT05425251 — BRAINI-2 Elderly Mild TBI European Study · completed
Other recruiting trials for Mild Traumatic Brain Injury (mTBI)
Currently open trials in the same condition.
- NCT06855186 — Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C) · NA · recruiting
Other Hospital Universitario 12 de Octubre trials
Trials by the same sponsor.
- NCT07473882 — Intraventricular Hemorrhage in Kangaroo Care vs. Incubator Care · NA · not yet recruiting
- NCT06698159 — Wide-Antral Pulmonary Vein Isolation in Atrial Fibrillation Ablation with a Single-shot Technique (WIDER-PVI) · NA · recruiting
- NCT07095829 — Prognostic Model of Postnatal Circulation in Pulmonary Atresia-critical Stenosis With Intact Ventricular Septum · recruiting
- NCT07183904 — Nerve and Hematoma Blocks for Pain Relief During Distal Radius Fracture Reduction · NA · completed
- NCT05653726 — Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF) · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07311486 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Universitario 12 de Octubre
- Last refreshed: 31 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07311486.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing