Subarachnoid Hemorrhage Clinical Trial
Official title:
Safety and Pharmacokinetic Evaluation of Sodium Nitrite Injection for the Prevention of Post-Subarachnoid Hemorrhage Induced Vasospasm
The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.
Intravenous sodium nitrite has been shown to prevent and to reverse cerebral vasospasm in a
primate model of subarachnoid hemorrhage (SAH). This was a Phase IIA dose escalation study of
sodium nitrite to determine its safety in patients with aneurysmal SAH and to establish its
pharmacokinetics during a 14 day infusion.
Sodium nitrite was delivered intravenously for 14 days in 18 patients with SAH from a
ruptured cerebral aneurysm using a dose escalation scheme in three cohorts of 6 patients each
(3 nitrite, 3 saline), with a maximum dose of 64 nmol/min/kg. Sodium nitrite blood levels
were frequently sampled and measured using mass spectroscopy and blood methemoglobin levels
were continuously monitored using a pulse oximeter.
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