Title

Magnesium Treating Subarachnoid Hemorrhage Vasospasm
Magnesium in Treating Subarachnoid Hemorrhage Related Vasospasm, A Haptoglobin Genomic Based Randomized Controlled Trial
  • Phase

    Phase 2/Phase 3
  • Study Type

    Interventional
  • Status

    Not yet recruiting
  • Study Participants

    200
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 Started
Dec 31
2021
Anticipated
Primary Completion
May 31
2022
Anticipated
Study Completion
Aug 31
2022
Anticipated
Last Update
Jul 02
2021

Drug 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

Drug normal saline

Placebo treatment

Magnesium arm Active Comparator

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.

Placebo arm Placebo Comparator

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

Criteria

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.
No Results Posted