Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage

Stopped early · Phase 2

Conditions studied: Subarachnoid Hemorrhage

In brief

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.

Key facts

Study ID

NCT02176837

Run by

Hope Pharmaceuticals

People needed

6

Starts

2014-06-01

Expected to finish

2017-01-15

Last updated by the study team

2018-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Virginia Medical Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.