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临床试验/NCT07252505
NCT07252505尚未招募1 期

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

Assiut University0 个研究点目标入组 50 人开始时间: 2025年11月1日最近更新:
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
50
主要终点
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

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

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)

干预措施: Magnesium Sulfate 10 MG/ML (Drug)

结局指标

主要结局

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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zeinab Salah El-Dein Quashty Aly

Emergency Medicine assistant lecturer

Assiut University

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