Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

Official title:

Evaluation of Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage From a Cerebral Aneurysm

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02176837
• Other study ID #: SN-03-01
• Status: Terminated
• Phase: Phase 2
• First received: February 19, 2014
• Last updated: March 4, 2018
• Start date: June 2014
• Est. completion date: January 15, 2017

Study information

• Verified date: March 2018
• Source: Hope Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 15, 2017
• Est. primary completion date: January 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

Drug:
• Sodium Nitrite
Subjects will receive continuous intravenous infusion of study drug for 7 days at a dose of 64 nmol/min/kg. The infusion will begin shortly after angiographic demonstration of cerebral vasospasm and will be for 7 days unless side effects of the drug dictate stopping the infusion.

Locations

Country	Name	City	State
United States	University of Virginia Medical Center	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hope Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Vasospasm	Cerebral digital subtraction angiographies will be reviewed at at least 2 time points, including at the time of diagnosis of angiographic vasospasm immediately before treatment with nitrite and after up to 180 minutes of nitrite infusion. Radiographs will be compared to determine whether increased flow of radiographic dye is visualized following initiation of nitrite infusion.	180 minutes