Safety and effect of SANGUINATE on patients DCI following SAH.
The purpose of this study is to study the safety and effect of SANGUINATE on patients suffering from delayed cerebral ischemia after acute aneurysmal subarachnoid hemorrhage.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
12
Single infusion of SANGUINATE (pegylated carboxyhemogloblin)
Barnes Jewish Hospital/Washington University
St Louis, Missouri, United States
Safety of study drug during and following infusion as measured by vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events
Safety assessments to include vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events
Time frame: Up to 30 days
Impact of SANGUINATE on brain oxygenation and blood flow assessed using Postitron Emission Tomography (PET)
Blood oxygenation and blood flow will be assessed using Postitron Emission Tomography (PET)
Time frame: Up to 30 days
Changes in neurological function measured by National Institutes of Health Stroke Scale (NIHSS)
Time frame: Up to 30 days
Incidence, location, and size of cerebral infarction as measured by MRI
Time frame: Up to 30 days
Changes in Blood Gases as measured by Hemoximetry
Time frame: Up to 30 days
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