Clinical trial NCT04613960: Magnesium Treating Subarachnoid Hemorrhage Vasospasm
Official title: Magnesium in Treating Subarachnoid Hemorrhage Related Vasospasm, A Haptoglobin Genomic Based Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Cerebral Vasospasm
Keywords: subarachnoid hemorrhage
Haptoglobin
Vasospasm
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
Collaborators: name: Ain Shams University
name: Health Insurance Organization, Egypt
First posted: 2020-11-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Clinical evidence and TCD measured MFV indicative of vasospasm
timeFrame: 14 days after onset
Secondary outcomes:
measure: Poor MRS functional score
timeFrame: 3 months after the onset
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El matareya Educational Hospital
Study officials:
References:
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.
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.
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.
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.
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.