Early Intravenous Magnesium Sulfate and Its Impact on Cerebral Vasospasm in Traumatic Subarachnoid Hemorrhage

Assiut University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Trauma and Emergency Care

Treatments: Drug: Magnesium Sulfate 10 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT07252505

Magnesium Sulfate

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Aneurysmal or spontaneous SAH Sever hepatic dysfunction.
• Known hypersensitivity to magnesium sulfate
• Renal disease with glomerular filtration rate<15 ml/min.
• pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Group A: patients will be given magnesium sulfate (MgSO4) with infusion rate (20- 40 mmol) per hour.

Placebo Comparator group

Description:

will be given magnesium sulfate (MgSO4) with infusion rate (20- 40 mmol)

Treatment:

Drug: Magnesium Sulfate 10 MG/ML

Group B: will be given normal saline (placebo group).

No Intervention group

Description:

will be given normal saline (placebo group).