Magnesium Treating Subarachnoid Hemorrhage Vasospasm

Phase 2

Not yet recruiting

• Conditions: Cerebral Vasospasm; Subarachnoid Hemorrhage, Aneurysmal
• Interventions: Drug: normal saline; Drug: Magnesium sulfate

• Registration Number: NCT04613960
• Lead Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-11-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-12
• Last Update Posted: 2022-09-13
• Study Start: 2022-12
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo arm	normal saline	patients randomized to placebo therapy with 0.9% saline (without active component) via same protocol.
Magnesium arm	Magnesium sulfate	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.

Primary Outcome Measures

Name	Time	Method
Clinical evidence and TCD measured MFV indicative of vasospasm	14 days after onset	Mean flow velocity measurements by TCD indicative of cerebral vasospasm. New clinical neurological deficit determined by comparing NIHSS pre and post detected vasospasm.

Secondary Outcome Measures

Name	Time	Method
Poor MRS functional score	3 months after the onset	Poor MRS score (4,5 or dead) assessed at regular follow up visits

Trial Locations

Locations (1)

El matareya Educational Hospital; 🇪🇬 Cairo, Egypt