Dexamethasone in Traumatic Brain Injury
The Impact of Early Use of Dexamethasone Traumatic Brain Injury Upon the Inflammatory Response and Outcome
1 other identifier
interventional
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2022
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedStudy Start
First participant enrolled
May 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 15, 2027
September 16, 2026
September 1, 2026
5.3 years
March 27, 2022
September 12, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with decreased the inflammatory response
Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements
48 hours post-interventional (either placebo or Dexamethasone)
Study Arms (2)
Group C
PLACEBO COMPARATORGroup C, will be received saline (loading dose of 5 ml of saline 0.9%, followed by a 5 ml saline 0.9% of maintenance saline dose every 6 hours for 48 h).
Group D
EXPERIMENTALGroup D, will be received Dexamethasone (loading dose of 10 mg Dexamethasone in 5 ml saline, followed by a 8 mg diluted in 5 ml saline of maintenance dose every 6hours for 48 h).
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- Isolated traumatic brain injury patients (mild or moderate cases)
- GCS \> 8
- non penetrating TBI in 8 hours onset
- Age ≥ 18 years
You may not qualify if:
- Patient in cardiac arrest
- Patients with coagulopathies
- All diabetic patients
- Renal failure patients
- pregnancy
- Patient refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut university hospital
Asyut, Assuit, Assuit universi, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of anesthesia and ICU
Study Record Dates
First Submitted
March 27, 2022
First Posted
April 12, 2022
Study Start
May 18, 2022
Primary Completion (Estimated)
September 10, 2027
Study Completion (Estimated)
October 15, 2027
Last Updated
September 16, 2026
Record last verified: 2026-09