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Magnesium Treating Subarachnoid Hemorrhage Vasospasm (MATSH-SHapE)

Primary Purpose

Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm

Status
Not yet recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium sulfate
normal saline
Sponsored by
General Committee of Teaching Hospitals and Institutes, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subarachnoid Hemorrhage, Aneurysmal focused on measuring subarachnoid hemorrhage, Haptoglobin, Vasospasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • El matareya Educational Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Magnesium arm

Placebo arm

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Poor MRS functional score
Poor MRS score (4,5 or dead) assessed at regular follow up visits

Full Information

First Posted
October 28, 2020
Last Updated
September 12, 2022
Sponsor
General Committee of Teaching Hospitals and Institutes, Egypt
Collaborators
Ain Shams University, Health Insurance Organization, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04613960
Brief Title
Magnesium Treating Subarachnoid Hemorrhage Vasospasm
Acronym
MATSH-SHapE
Official Title
Magnesium in Treating Subarachnoid Hemorrhage Related Vasospasm, A Haptoglobin Genomic Based Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Committee of Teaching Hospitals and Institutes, Egypt
Collaborators
Ain Shams University, Health Insurance Organization, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm
Keywords
subarachnoid hemorrhage, Haptoglobin, Vasospasm

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnesium arm
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
patients randomized to placebo therapy with 0.9% saline (without active component) via same protocol.
Intervention Type
Drug
Intervention Name(s)
Magnesium sulfate
Intervention Description
MgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Placebo treatment
Primary Outcome Measure Information:
Title
Clinical evidence and TCD measured MFV indicative of vasospasm
Description
Mean flow velocity measurements by TCD indicative of cerebral vasospasm. New clinical neurological deficit determined by comparing NIHSS pre and post detected vasospasm.
Time Frame
14 days after onset
Secondary Outcome Measure Information:
Title
Poor MRS functional score
Description
Poor MRS score (4,5 or dead) assessed at regular follow up visits
Time Frame
3 months after the onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Ateia
Phone
+201202474777
Email
a_ateia@hotmail.com
Facility Information:
Facility Name
El matareya Educational Hospital
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Ateia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
IPD Sharing Time Frame
starting 6 months after publication
Citations:
PubMed Identifier
24619389
Citation
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.
Results Reference
background
PubMed Identifier
30409409
Citation
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.
Results Reference
background
PubMed Identifier
23781295
Citation
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.
Results Reference
background
PubMed Identifier
18032779
Citation
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.
Results Reference
background
PubMed Identifier
33069930
Citation
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.
Results Reference
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Magnesium Treating Subarachnoid Hemorrhage Vasospasm

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