Clinical trial NCT02176837: Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage
Official title: Evaluation of Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage From a Cerebral Aneurysm
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Subarachnoid Hemorrhage
Keywords: subarachnoid hemorrhage
vasospasm
nitrite
sodium nitrite
Lead sponsor: Hope Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility 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.

Primary outcomes:
measure: Cerebral Vasospasm
timeFrame: 180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: University of Virginia Medical Center, Department of Neurosurgery
name: Kenny Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: