Dexamethasone for the treatment of traumatic brain injured patients with brain contusions and pericontusional edema: Study protocol for a prospective, randomized and double blind trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520887-17-00

Enrollment

Registered

2026-03-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic brain contusion with edema

Brief summary

To evaluate the efficacy of treatment with dexamethasone compared to placebo, measured by the proportion of patients who, one month after the trauma, present good evolution according to the “Extended Glasgow Outcome Scale (GOSE)”.

Interventions

DRUG10 g Celulosa microcristalina 250 g Acofarma CL 0

DRUG1 g Riboflavina (vit. B2) (vit. B2) 250 g Acofarma 200 cáps Cápsulas Nº4 blancas-verdes 1000 Ud Acofarma

DRUGFortecortin 4 mg tablety

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of treatment with dexamethasone compared to placebo, measured by the proportion of patients who, one month after the trauma, present good evolution according to the “Extended Glasgow Outcome Scale (GOSE)”.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 27, 2026