Magnesium Treating Subarachnoid Hemorrhage Vasospasm

Study Overview
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Brief Summary
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A randomized clinical trial investigating magnesium sulphate ability to reduce risk of cerebral vasospasm after acute subarachnoid hemorrhage hence improving outcome particularly in haptoglobin 2-2 patients who are highly susceptible for severe complications after subarachnoid hemorrhage.

Detailed Description
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Study Design and Location: Investigators propose a double blinded, randomized (1:1), placebo-controlled, multicenter, clinical trial including patients with acute aSAH. Participants will be allocated either to MgSO4 or placebo. The permission to conduct the study protocol will be considered for approval by the ethics committee of General Committee of Teaching Hospitals and Institutes (GCTHI), Egypt. The study will be conducted in 3 centers; El-Materia Educational Hospital, Ain Shams University Hospitals and Nasr City Insurance Hospital. The assigned centers for this study represent large-volume referral stroke centers that provide comprehensive management protocols for aSAH.

Official Title
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Magnesium in Treating Subarachnoid Hemorrhage Related Vasospasm, A Haptoglobin Genomic Based Randomized Controlled Trial

Conditions
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Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm

Intervention / Treatment
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* Drug: Magnesium sulfate
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both genders age over 18 years old diagnosis of acute aSAH (≤ 48 hours) confirmed with angiographic evidence of cerebral aneurysm and CT brain on admission. Exclusion Criteria: subarachnoid hemorrhage due to non-aneurysmal causes cerebral stroke of any type during past month decompensated heart failure, renal failure or hepatic failure difficult bilateral transtemporal transcranial Doppler (TCD) insonation of intracranial arteries due to thick temporal bone of the skull.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium arm<br>patients randomized to magnesium therapy at a fixed daily dose of 64 mmol reconstituted in 0.9% saline via continuous intravenous infusion for 14 days after hemorrhage onset, or until discharge or death if it occurred. | Drug: Magnesium sulfate<br>* MgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset<br>|
| Placebo Comparator: Placebo arm<br>patients randomized to placebo therapy with 0.9% saline (without active component) via same protocol. | Drug: normal saline<br>* Placebo treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evidence and TCD measured MFV indicative of vasospasm | Mean flow velocity measurements by TCD indicative of cerebral vasospasm. New clinical neurological deficit determined by comparing NIHSS pre and post detected vasospasm. | 14 days after onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poor MRS functional score | Poor MRS score (4,5 or dead) assessed at regular follow up visits | 3 months after the onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subarachnoid hemorrhage, Haptoglobin, Vasospasm