Not yet recruiting NCT07252505

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

Early Phase I Interventional Trauma and Emergency Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Magnesium Sulfate 10 MG/ML.
Who it may be relevant to: Registry conditions: Trauma and Emergency Care. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

Drug Magnesium Sulfate 10 MG/ML
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

Primary outcome measures

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".]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07252505 · Magnesium Sulfate

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗