Cerebral Vasospasm, Subarachnoid Hemorrhage, Aneurysmal
Conditions
Keywords
subarachnoid hemorrhage, Haptoglobin, Vasospasm
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.
Interventions
DRUGMagnesium sulfate
MgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset
DRUGnormal saline
Placebo treatment
Sponsors
Ain Shams University
Health Insurance Organization, Egypt
General Committee of Teaching Hospitals and Institutes, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Poor MRS functional score | 3 months after the onset | Poor MRS score (4,5 or dead) assessed at regular follow up visits |
Countries
Egypt
Contacts
Primary ContactAhmed M Ateia
Outcome results
None listed