Cerebral Ischemia
Conditions
Keywords
DCI, Delayed Cerebral Ischemia, SAH, Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage, Cerebral Ischemia, Brain Ischemia
Brief summary
Safety and effect of SANGUINATE on patients DCI following SAH.
Detailed description
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.
Interventions
BIOLOGICALSANGUINATE™
Single infusion of SANGUINATE (pegylated carboxyhemogloblin)
Sponsors
Prolong Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Signed and dated written informed consent by the subject or his/her legally authorized representative; * Modified Rankin (mRankin) score of 0 or 1 prior to the onset of subarachnoid hemorrhage; * Ruptured aneurysm secured by endovascular coil embolization or surgical clipping (the Procedure), not more than 72 hours after the onset of subarachnoid hemorrhage; and * Hunt and Hess (H&H) grade 3 or 4, or World Federation of Neurological Surgeons (WFNS) score 3 or 4 prior to the Procedure, and Modified Fisher (mFisher) grade 3 or 4, prior to the Procedure; or * Clinical signs of (symptomatic) delayed cerebral ischemia; or * Angiographic evidence of cerebral vasospasm
Exclusion criteria
* In the judgment of the Investigator the patient is not a good candidate for the study * Evidence of rebleed following the Procedure * Subarachnoid hemorrhage secondary to trauma or to arteriovenous malformation * Diagnosed moderate to severe pulmonary hypertension * Radiologically confirmed moderate to severe pulmonary edema (as shown by the presence of Kerley lines, peribronchial cuffing, thickened interlobar fissure, consolidation and/or pleural effusion) * History within the past 6 months and/or finding of decompensated heart failure * Acute myocardial infarction within 3 months prior to the administration of the study drug * Left ventricular ejection fraction \<40%, as determined by prior echocardiography or clinical signs of CHF * Medical history or concurrent evidence of moderate to severe renal insufficiency (estimated creatinine clearance \< 30 mL/min)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of study drug during and following infusion as measured by vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events | Up to 30 days | Safety assessments to include vital signs, clinical signs, bioanalytical measures, or investigational drug-related adverse events |
| Impact of SANGUINATE on brain oxygenation and blood flow assessed using Postitron Emission Tomography (PET) | Up to 30 days | Blood oxygenation and blood flow will be assessed using Postitron Emission Tomography (PET) |
Secondary
| Measure | Time frame |
|---|---|
| Changes in neurological function measured by National Institutes of Health Stroke Scale (NIHSS) | Up to 30 days |
| Incidence, location, and size of cerebral infarction as measured by MRI | Up to 30 days |
| Changes in Blood Gases as measured by Hemoximetry | Up to 30 days |
Countries
United States
Outcome results
None listed