Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage

Phase 2

Terminated

• Conditions: Subarachnoid Hemorrhage
• Interventions: Drug: Sodium Nitrite

• Registration Number: NCT02176837
• Lead Sponsor: Hope Pharmaceuticals

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).

Study Timeline

• Study First Submitted: 2014-02-19
• Study Start: 2014-06
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-27
• Primary Completion: 2017-01-15
• Study Completion: 2017-01-15
• Results First Submitted: 2018-01-14
• Results First Submitted QC: 2018-01-14
• Results First Posted: 2018-02-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-04
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sodium Nitrite	Sodium Nitrite	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).

Primary Outcome Measures

Name	Time	Method
Cerebral Vasospasm	180 minutes	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.

Trial Locations

Locations (1)

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States