Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage

• Status: Terminated
• Trial end date: 2017-01-15
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis is that intravenous infusion of sodium nitrite is safe and effective for the reversal of cerebral vasospasm after subarachnoid hemorrhage in patients with a cerebral aneurysm.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hope Pharmaceuticals

Criteria

Inclusion Criteria:

• Informed consent obtained from a patient or legal representative before enrollment;

• Admission to hospital following subarachnoid hemorrhage;

• Aneurysm confirmed by digital subtraction angiography or CT-angiography after admission;

• Development of the clinical symptoms and /or signs of cerebral vasospasm and CT-angiography results warranting cerebral angiography.

Exclusion Criteria:

• Rupture of a fusiform, traumatic, or mycotic aneurysm;

• Pregnancy (confirmed by a serum human chorionic gonadotropin pregnancy test) or breast feeding;

• Methemoglobin > 2%

• History of sickle cell disease, thalassemia, or other hemoglobinopathy;

• Anemia with hemoglobin level less than 6 g/dL;

• Significant acute or chronic concomitant diseases (including renal, hepatic, cardiovascular, pulmonary, or oncologic disease, sepsis, pulmonary edema, pulmonary embolism) that would be inconsistent with survival for at least 6 months;

• History of allergy to nitrites or allergy to other substances that could interfere with nitrite metabolism, within 30 days before screening;

• History of red blood cell glucose-6-phosphate dehydrogenase (G6PD)deficiency;

• Treatment with allopurinol, a medication that could interfere with nitrite metabolism, within 30 days before screening;

• Other investigational drug within the past 30 days;

• other cerebral injury within the past 30 days including previous subarachnoid hemorrhage, stroke, transient ischemic attacks (TIA), concussion, head trauma, cranial surgery, radiation therapy to the head.