Dexamethasone in Traumatic Brain Injury

The Impact of Early Use of Dexamethasone Traumatic Brain Injury Upon the Inflammatory Response and Outcome

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05323149

Enrollment

Registered

2022-04-12

Start date

2022-05-18

Completion date

2027-10-15

Last updated

2026-09-16

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

Conditions

Inflammatory Response

Brief summary

In this study, our aim is to investigate the role of Dexamethasone for modulating the inflammation in patients with traumatic brain injury (TBI).

Detailed description

This is double-blind trial, where group D will be received Dexamethasone, where group C will be received saline placebo. In emergency room (ER), trauma patients will be assessed and managed according to our local hospital protocol. After the initial resuscitation of patients. The selection was done according to the inclusion criteria. Baseline investigations 1. C-reactive protein (CRP), interleukin -6(IL-6), C-reactive protein/Albumin ratio (CAR), complete blood count (CBC) for neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR). 2. Prothrombin concentration (PC), prothrombin time (PT), activated partial thromboplastin time (aPTT), and INR. Group D, will be received Dexamethasone (loading dose of 10 mg in 5 ml saline, followed by a 8 mg in 5 ml saline of maintenance dose every 6 hours for 48 h). Group C, will be received saline (loading dose of 5 ml saline 0.9%, followed by a 5 ml saline 0.9% of maintenance saline dose every 6 hours for 48 h) to monitor the post-interventional inflammatory response (CBC for NLR, PLR), CRP, IL-6, C-reactive protein/Albumin ratio (CAR), hemostasis (PC, PT, activated PTT, and international normalized ratio (INR)) and short-term outcome. Conscious level will be assessed by Glasgow come scale (GCS), delirium by Richmond Agitation-Sedation Scale (RASS score) and hemodynamics will be continuously monitored. Patients will be monitored and managed in intermediate or intensive care unit. Adverse effects and complications will be recorded and managed.

Interventions

OTHERSaline

Giving saline 0.9% (loading dose of 5 ml of saline 0.9%, followed by a 5 ml of maintenance saline 0.9% dose every 6 hours for 48 h).

DRUGDexamethasone

Giving Dexamethasone (loading dose of 10 mg dilutedin 5 ml saline, followed by a 8 mg in 5 ml saline of maintenance dose every 6 hours for 48 h).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Isolated traumatic brain injury patients (mild or moderate cases) * GCS \> 8 * non penetrating TBI in 8 hours onset * Age ≥ 18 years

Exclusion criteria

* Patient in cardiac arrest * Patients with coagulopathies * All diabetic patients * Renal failure patients * pregnancy * Patient refusal to participate

Design outcomes

Primary

Measure	Time frame	Description
Percentage of patients with decreased the inflammatory response	48 hours post-interventional (either placebo or Dexamethasone)	Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements

Countries

Egypt

Contacts

CONTACTOmar Soliman

omar@aun.edu.eg01101266040

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026