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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
MgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset
Placebo treatment
El matareya Educational Hospital
Cairo, Egypt
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.
Time frame: 14 days after onset
Poor MRS functional score
Poor MRS score (4,5 or dead) assessed at regular follow up visits
Time frame: 3 months after the onset
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