Trauma and Emergency CareEarly Phase 1NCT07252505
Early Intravenous Magnesium Sulfate and Its Impact on Cerebral Vasospasm in Traumatic Subarachnoid Hemorrhage
A Early Phase 1 study testing Magnesium Sulfate 10 MG/ML in people with Trauma and Emergency Care, run by Assiut University.
Trial summary
Subarachnoid hemorrhage (SAH) is a clinical phenomenon caused by the abrupt rupture and bleeding of blood vessels at the surface or base of the brain, which can occur for a number of reasons. As a result, the subarachnoid membrane receives direct blood flow. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma and Emergency Care
- What is being tested?
- Magnesium Sulfate 10 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2025to Oct 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between eighteen to sixty five years Diagnosed with tSAH on Head Computed Tomography(CT)within 24 hours of trauma.
- Both Genders are included Indication for endovascular or microsurgical treatment plan
Who cannot join
- Aneurysmal or spontaneous SAH Sever hepatic dysfunction.
- Known hypersensitivity to magnesium sulfate
- Renal disease with glomerular filtration rate<15 ml/min.
- pregnancy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Subarachnoid hemorrhage (SAH) is a clinical phenomenon caused by the abrupt rupture and bleeding of blood vessels at the surface or base of the brain, which can occur for a number of reasons. As a result, the subarachnoid membrane receives direct blood flow. SAH is a debilitating neurological disorder with high morbidity and mortality. Despite advancements in medicine and surgical care, patients who survive their first bleeding event are at high risk for secondary sequelae, including delayed cerebral ischemia (DCI) and cerebral vasospasm (CV)
CV denotes a temporary, self-resolving constriction of the intracranial arteries that occurs several days after an SAH. This phenomenon is closely linked to clinical deterioration resulting from DCI, affecting up to 30% to 40% of patients. DCI is a significant clinical event that typically manifests 3 to 14 days after the initial bleeding and is characterized by subsequent neurological deterioration. These complications can lead to poor functional outcomes and long-term disability
Subarachnoid hemorrhage is classified into aneurysmal subarachnoid hemorrhage (aSAH) and Traumatic SAH (tSAH). TSAH has been described as an adverse prognostic factor leading to progressive neurological deterioration and increased morbidity and mortality. Traumatic subarachnoid hemorrhage is caused by head injuries from events like falls, motor vehicle crashes, and blows to the head, which damage blood vessels within the skull. The injury itself is the primary cause, leading to the brain being hit against the skull and tearing these blood vessels
Read the detailed description
Magnesium is a noncompetitive calcium antagonist with several important vascular and potentially neuro-protective effects. For instance, magnesium can lead to vasodilatation by blocking the voltage-dependent calcium channel and decreasing glutamate release and block the influx of calcium ions, inhibiting blood vessel contraction and preventing CV.In addition, magnesium also attenuates the effect of various potent vasoconstrictors, such as endothelin 1, and blocks the formation of reactive oxygen species These potentially helpful effects of magnesium on vasodilation and consequent neuro-protection has led some investigators to study the ability of magnesium to prevent of cerebral vasospasm and delayed cerebral ischemia after subarachnoid hemorrhage (SAH). Limited data exist for tSAH. Early intravenous Magnesium Sulfate (MgSO₄)application within 24 hours after diagnosis may prevent or attenuate vasospasm and improve neurological recovery and outcome
- Conditions
- Trauma and Emergency Care
- Being tested
- Magnesium Sulfate 10 MG/ML
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate 10 MG/MLDrug
Also called MgSo4
As a rule, MgSO4 will be given(for group A) within 24 hours after establishing a diagnosis of tSAH. The protocol will include MgSO4 10% application with a loading dose of 50 mg/kg body weight over 1 hour. The infusion rate (20-40 mmol) per hour will depend on blood pressure with a target mean arterial pressure of 65 mm Hg. Thereafter, patients will receive a continuous application of 81 mmol/ 24 hours for a maximum of 7 days. Target Serum Magnesium Levels Serum magnesium levels will be monitored daily during the infusion period. The target therapeutic range for serum magnesium will be between 2.0-2.5 mmol/L. If the serum magnesium level exceeds the upper limit (2.5 mmol/L), the infusion rate will be reduced, and the patient will be closely monitored for signs of magnesium toxicity, such as hypotension, bradycardia, respiratory depression, or reflexes loss. In the event of severe hyper-magnesemia, calcium gluconate will be administered as an antidote.
| Study group | Role | What they receive |
|---|---|---|
| Group A: patients will be given magnesium sulfate (MgSO4) with infusion rate (20- 40 mmol) per hour. | Placebo comparator | will be given magnesium sulfate (MgSO4) with infusion rate (20- 40 mmol) Receives: Drug: Magnesium Sulfate 10 MG/ML |
| Group B: will be given normal saline (placebo group). | No intervention | will be given normal saline (placebo group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effect of early intravenous magnesium sulfate on the incidence and severity of cerebral vasospasm in patients with traumatic subarachnoid hemorrhage assessed by cerebral blood flow velocity measured Through Transcranial Doppler
To evaluate the effect of early intravenous magnesium sulfate on the incidence and severity of cerebral vasospasm in patients with traumatic subarachnoid hemorrhage assessed by cerebral blood flow velocity measured Through Transcranial Doppler
Measured: From Day 1 immediately poat trauma (baseline) till an average of 7 Days".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma and Emergency CareStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Salah El-Dein Quashty Aly, Assiut University
- Investigators
- Zeinab Quashty, MD, Principal investigator, Assisstant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252505
- Sponsor's protocol ID
- Magnesium Sulfate
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intravenous Magnesium Sulfate and Its Impact on Cerebral Vasospasm in Traumatic Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT07252505
- Acronym / sponsor ID
- Magnesium Sulfate
- Conditions
- Trauma and Emergency Care
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subarachnoid hemorrhage (SAH) is a clinical phenomenon caused by the abrupt rupture and bleeding of blood vessels at the surface or base of the brain, which can occur for a number of reasons. As a result, the subarachnoid membrane receives direct blood flow. SAH is a debilitating neurological disorder with high morbidity and mortality. Despite advancements in medicine and surgical care, patients who survive their first bleeding event are at high risk for secondary sequelae, including delayed cerebral ischemia (DCI) and cerebral vasospasm (CV)
CV denotes a temporary, self-resolving constriction of the intracranial arteries that occurs several days after an SAH. This phenomenon is closely linked to clinical deterioration resulting from DCI, affecting up to 30% to 40% of patients. DCI is a significant clinical event that typically manifests 3 to 14 days after the initial bleeding and is characterized by subsequent neurological deterioration. These complications can lead to poor functional outcomes and long-term disability
Subarachnoid hemorrhage is classified into aneurysmal subarachnoid hemorrhage (aSAH) and Traumatic SAH (tSAH). TSAH has been described as an adverse prognostic factor leading to progressive neurological deterioration and increased morbidity and mortality. Traumatic subarachnoid hemorrhage is caused by head injuries from events like falls, motor vehicle crashes, and blows to the head, which damage blood vessels within the skull. The injury itself is the primary cause, leading to the brain being hit against the skull and tearing these blood vessels
Detailed description
Magnesium is a noncompetitive calcium antagonist with several important vascular and potentially neuro-protective effects. For instance, magnesium can lead to vasodilatation by blocking the voltage-dependent calcium channel and decreasing glutamate release and block the influx of calcium ions, inhibiting blood vessel contraction and preventing CV.In addition, magnesium also attenuates the effect of various potent vasoconstrictors, such as endothelin 1, and blocks the formation of reactive oxygen species These potentially helpful effects of magnesium on vasodilation and consequent neuro-protection has led some investigators to study the ability of magnesium to prevent of cerebral vasospasm and delayed cerebral ischemia after subarachnoid hemorrhage (SAH). Limited data exist for tSAH. Early intravenous Magnesium Sulfate (MgSO₄)application within 24 hours after diagnosis may prevent or attenuate vasospasm and improve neurological recovery and outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: patients will be given magnesium sulfate (MgSO4) with infusion rate (20- 40 mmol) per hour. | Placebo comparator | Drug: Magnesium Sulfate 10 MG/MLwill be given magnesium sulfate (MgSO4) with infusion rate (20- 40 mmol) |
| Group B: will be given normal saline (placebo group). | No intervention | –will be given normal saline (placebo group). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged between eighteen to sixty five years Diagnosed with tSAH on Head Computed Tomography(CT)within 24 hours of trauma.
- Both Genders are included Indication for endovascular or microsurgical treatment plan
Key exclusion criteria (4 listed)
- Aneurysmal or spontaneous SAH Sever hepatic dysfunction.
- Known hypersensitivity to magnesium sulfate
- Renal disease with glomerular filtration rate<15 ml/min.
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate 10 MG/MLAlso: MgSo4As a rule, MgSO4 will be given(for group A) within 24 hours after establishing a diagnosis of tSAH. The protocol will include MgSO4 10% application with a loading dose of 50 mg/kg body weight over 1 hour. The infusion rate (20-40 mmol) per hour will depend on blood pressure with a target mean arterial pressure of 65 mm Hg. Thereafter, patients will receive a continuous application of 81 mmol/ 24 hours for a maximum of 7 days. Target Serum Magnesium Levels Serum magnesium levels will be monitored daily during the infusion period. The target therapeutic range for serum magnesium will be between 2.0-2.5 mmol/L. If the serum magnesium level exceeds the upper limit (2.5 mmol/L), the infusion rate will be reduced, and the patient will be closely monitored for signs of magnesium toxicity, such as hypotension, bradycardia, respiratory depression, or reflexes loss. In the event of severe hyper-magnesemia, calcium gluconate will be administered as an antidote. | Drug | Group A: patients will be given magnesium sulfate (MgSO4) with infusion rate (20- 40 mmol) per hour. |
Primary outcome
To evaluate the effect of early intravenous magnesium sulfate on the incidence and severity of cerebral vasospasm in patients with traumatic subarachnoid hemorrhage assessed by cerebral blood flow velocity measured Through Transcranial Doppler
Time frame: From Day 1 immediately poat trauma (baseline) till an average of 7 Days".
To evaluate the effect of early intravenous magnesium sulfate on the incidence and severity of cerebral vasospasm in patients with traumatic subarachnoid hemorrhage assessed by cerebral blood flow velocity measured Through Transcranial Doppler
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zeinab Quashty, MD principal investigator
Assisstant lecturer
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Magnesium Sulfate 10 MG/ML in people with Trauma and Emergency Care, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeinab Quashty, MD (0021143751762, zeinabsalah404@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of early intravenous magnesium sulfate on the incidence and severity of cerebral vasospasm in patients with traumatic subarachnoid hemorrhage assessed by cerebral blood flow velocity measured Through Transcranial Doppler (time frame: From Day 1 immediately poat trauma (baseline) till an average of 7 Days".). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.