Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) Following Subarachnoid Hemorrhage (SAH)

Study Overview
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Brief Summary
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Safety and effect of SANGUINATE on patients DCI following SAH.

Detailed Description
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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.

Official Title
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Single Escalating-dose, Open-label Study to Assess the Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) After Acute Aneurysmal Subarachnoid Hemorrhage (SAH)

Conditions
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Cerebral Ischemia

Intervention / Treatment
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* Biological: SANGUINATE™


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SANGUINATE™<br>Single infusion of SANGUINATE (pegylated carboxyhemogloblin) | Biological: SANGUINATE™<br>* Single infusion of SANGUINATE (pegylated carboxyhemogloblin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | Up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DCI, Cerebral Ischemia, Delayed Cerebral Ischemia, SAH, Subarachnoid Hemorrhage, Aneurysmal Subarachnoid Hemorrhage, Brain Ischemia