Magnesium Treating Subarachnoid Hemorrhage Vasospasm (MATSH-SHapE)

General Committee of Teaching Hospitals and Institutes, Egypt

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Subarachnoid Hemorrhage, Aneurysmal; Cerebral Vasospasm

Treatments: Drug: Magnesium sulfate; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04613960

MTH/NEUR/20/01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Magnesium arm

Active Comparator group

Description:

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.

Treatment:

Drug: Magnesium sulfate

Placebo arm

Placebo Comparator group

Description:

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

Treatment:

Drug: normal saline