Magnesium Treating Subarachnoid Hemorrhage Vasospasm

NCT04613960 | Unknown Phase 2 DMC

• 1 other identifier: MTH/NEUR/20/01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage, Aneurysmal; Cerebral Vasospasm

Keywords

subarachnoid hemorrhage; Haptoglobin; Vasospasm

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days after onset

Secondary Outcomes (1)

• Poor MRS functional score

  3 months after the onset

Study Arms (2)

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.

Drug: Magnesium sulfate

Placebo arm

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

Magnesium sulfate DRUG

MgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset

Magnesium arm

normal saline DRUG

Placebo treatment

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead
• Ain Shams University: collaborator
• Health Insurance Organization, Egypt: collaborator

Study Sites (1)

El matareya Educational Hospital

Cairo, Egypt

Location

Related Publications (5)

• Reddy D, Fallah A, Petropoulos JA, Farrokhyar F, Macdonald RL, Jichici D. Prophylactic magnesium sulfate for aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. Neurocrit Care. 2014 Oct;21(2):356-64. doi: 10.1007/s12028-014-9964-0.

  PMID: 24619389 BACKGROUND

• Soliman R, Zohry G. [Effect of magnesium sulphate and milrinone on cerebral vasospasm after aneurysmal subarachnoid hemorrhage: a randomized study]. Braz J Anesthesiol. 2019 Jan-Feb;69(1):64-71. doi: 10.1016/j.bjan.2018.09.005. Epub 2018 Nov 6.

  PMID: 30409409 BACKGROUND

• Thomsen JH, Etzerodt A, Svendsen P, Moestrup SK. The haptoglobin-CD163-heme oxygenase-1 pathway for hemoglobin scavenging. Oxid Med Cell Longev. 2013;2013:523652. doi: 10.1155/2013/523652. Epub 2013 May 27.

  PMID: 23781295 BACKGROUND

• Milman U, Blum S, Shapira C, Aronson D, Miller-Lotan R, Anbinder Y, Alshiek J, Bennett L, Kostenko M, Landau M, Keidar S, Levy Y, Khemlin A, Radan A, Levy AP. Vitamin E supplementation reduces cardiovascular events in a subgroup of middle-aged individuals with both type 2 diabetes mellitus and the haptoglobin 2-2 genotype: a prospective double-blinded clinical trial. Arterioscler Thromb Vasc Biol. 2008 Feb;28(2):341-7. doi: 10.1161/ATVBAHA.107.153965. Epub 2007 Nov 21.

  PMID: 18032779 BACKGROUND

• Ateia AM, Elbassiouny A, El-Nabi SH, Fahmy NA, Ibrahim MH, El-Garawani I, Geba KM, Khalaf M. Predictive value of haptoglobin genotype as a risk of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Clin Neurol Neurosurg. 2020 Dec;199:106296. doi: 10.1016/j.clineuro.2020.106296. Epub 2020 Oct 7.

  PMID: 33069930 RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Ahmed M Ateia

CONTACT

+201202474777; a_ateia@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology Specialist, MTH; Associate member, Harvard Medical School.

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 6 months after publication

Locations

EG (1)