Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage

Hope Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Subarachnoid Hemorrhage

Treatments

Drug: Sodium Nitrite

Study type

Interventional

Funder types

Industry

Identifiers

NCT02176837

SN-03-01

Details and patient eligibility

About

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.

Full description

This is a pilot single center, open-labeled study. Patients with subarachnoid hemorrhage admitted to the hospital and who meet entry criteria will be offered enrollment into the study. The patients will be enrolled promptly after detection of the presence of cerebral vasospasm. Subjects will receive sodium nitrite infusion.

One dose cohort is planned, 64 nmol/min/kg sodium nitrite (0.1325 mg/hour/kg; 0.0442 ml/hour/kg at a concentration of 3mg/ml).

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.