NCT04613960

Magnesium Treating Subarachnoid Hemorrhage Vasospasm

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Subarachnoid Hemorrhage, Aneurysmal
• Cerebral Vasospasm

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2020-11-03
• Last updated: 2022-09-13

Locations

1 site across 1 country: Egypt