Magnesium Treating Subarachnoid Hemorrhage Vasospasm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2024-06-30

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.

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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.

Conditions

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Subarachnoid Hemorrhage, Aneurysmal Cerebral Vasospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Magnesium arm

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.

Group Type ACTIVE_COMPARATOR

Magnesium sulfate

Intervention Type DRUG

MgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset

Placebo arm

patients randomized to placebo therapy with 0.9% saline (without active component) via same protocol.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Placebo treatment

Interventions

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Magnesium sulfate

MgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset

Intervention Type DRUG

normal saline

Placebo treatment

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes