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Can a common mineral ease brain swelling after trauma?

NCT ID NCT07763665

Disease control Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether giving magnesium sulfate soon after a moderate traumatic brain injury can reduce harmful inflammation in the brain. Adults aged 18–60 with a moderate head injury will receive either magnesium sulfate or a saltwater placebo within 8 hours of injury. Researchers will measure changes in a key inflammatory marker (NLRP3) and track patients' recovery and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Magnesium sulfate (MgSO4) given intravenously, compared with normal saline (placebo).
What this could lead to
If effective, magnesium sulfate could become a simple, widely available anti-inflammatory treatment to improve recovery after moderate traumatic brain injury.
What could go wrong
This is a small, early-phase trial (64 patients) measuring a biomarker, not long-term outcomes. Magnesium can cause side effects like low blood pressure or toxicity, and results may not generalize.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female patients aged 18 to 60 years. 2. Sustained a closed head trauma with the study drug infusion initiated within 8 hours of the injury. 3. TBI confirmed by history and clinical examination. 4. Patients with moderate (GCS = 9-12) traumatic brain injury. 5. Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification ). 6. Hemodynamic stability at the time of enrollment. Exclusion Criteria: 1. Patient Refusal 2. Prolonged and/or uncorrectable hypoxia (PaO₂ \< 60 mmHg) or persistent hypotension (systolic blood pressure \< 90 mmHg) at the time of randomization. 3. Cardiopulmonary arrest. 4. Concomitant spinal cord injury. 5. Pregnant or lactating females. 6. Penetrating head injury. 7. Associated other extra-cranial trauma or systemic polytrauma. 8. Undergoing surgical interventions during the study. 9. Pre-existing severe cardiac arrhythmia, heart block, or significant myocardial damage (documented on ECG). 10. Known history of chronic renal failure or abnormal baseline renal function. 11. Known hypersensitivity or allergic reaction to magnesium sulfate. 12. Patients on chronic steroid therapy. 13. BMI\>35 kg/m2. \-

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Traumatic brain injuries

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.