Subarachnoid Hemorrhage Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Pilot Trial to Investigate Safety and Efficacy of Cerebrolysin™ in Patients With Aneurysmal Subarachnoid Hemorrhage
This is a randomized, placebo-controlled, single-center clinical trial investigating the
effectiveness of administrating intravenous Cerebrolysin™ (EVER NEURO Pharma, Austria), a
preparation of low-molecular weight neurotrophic peptides and free amino acids, in improving
the functional outcome of patients suffering from aneurysmal subarachnoid haemorrhage ( SAH).
Cerebrolysin™ is a porcine-derived intravenous formulation composed of multiple lipid-soluble
active agents that can cross the blood-brain barrier. It is a registered medication in
several countries indicated for stroke and Alzheimer's disease. It contains several low
molecular weight neuropeptides and free amino acids that possess neuroprotective and
neurotrophic properties. It has been proven to arrest or mitigate several crucial steps along
the ischemic cascade in preclinical studies. Cerebrolysin™ has been extensively investigated
in patients suffering from Alzheimer's disease, brain trauma and ischemic stroke with
promising clinical results. It's use in SAH patients has never been investigated and it is
believed that it may play a role in improving clinical outcomes.
Consecutive patients aged 18 to 70 years-old diagnosed to have spontaneous subarachnoid
hemorrhage secondary to a ruptured intracranial aneurysm will be randomly allocated into one
of two study arms: (1) to receive intravenous Cerebrolysin™ in additional to standard of care
(intervention group) or (2) to receive usual standard of care alone (control group).
Permuted-block randomization will be carried out once the eligibility criteria have been
fulfilled using a computer system with an allocation list of random order. Instructions on
study arm allocation will be contained in sealed envelopes labeled with sequential study
numbers. Patients presenting beyond 96 hours after onset of symptoms or if recruitment and
randomization cannot be performed within this time period will be excluded. The reason being
that post-SAH arterial vasospasm and delayed cerebral ischemia usually occurs four days after
aneurysm rupture and lasts for two weeks i.e. 14 days. Should this complication arise before
Cerebrolysin™ is administered there would be significant confounding of trial outcome
measures . The timing of intervention is in keeping with several landmark clinical studies
that have dealt with neuroprotective agents in subarachnoid hemorrhage.
Patients in the intervention group will receive in a daily total dose of 30ml of intravenous
Cerebrolysin™. The study medication will be administered in three separate 10ml doses (every
eight hours) diluted in 0.9% NaCl saline to a total volume of 100 ml as an intravenous
infusion over a time period of 15 minutes. An identical amount of 0.9% sodium chloride (NaCl)
saline (100 ml) will be used as placebo for patients allocated to the control study group.
The total duration of study medication or placebo administration will be 14 days.
Cerebrolysin™ is a clear yellow solution. Since it is susceptible to photo-degeneration the
preparation after dilution with 0.9% NaCl saline requires masking with a opaque plastic wrap
as well as special photo-protective infusion sets. The dilution of the Cerebrolysin™ solution
will be performed by ward nursing staff . Subjects in both trial groups will receive
identically wrapped preparations so that both the functional outcomes assessor and patient
are blind to the study arm allocation.
In addition to general demographic data, clinical data including the admission Glasgow Coma
Score, severity grading of SAH, hospital stay as well as the extended Glasgow Outcome Score
and modified Rankin Score upon discharge, at three months and six months will be
prospectively collected. The functional outcomes assessor will be an occupational therapist
unaware of the subject's trial group allocation.
Hypothesis: compared to patients receiving standard care for the management of aneurysmal
subarachnoid hemorrhage alone (control), the additional administration of intravenous
Cerebrolysin™ (intervention) within the acute phase of stroke is safe and improves functional
outcome at six months after stroke.
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