Suspended

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

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What is being tested

Sodium Nitrite

Drug
Who is being recruted

Brain Diseases+8

+ Cardiovascular Diseases

+ Central Nervous System Diseases

Over 18 Years
+15 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2014
See protocol details

Summary

Principal SponsorHope Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2014

Actual date on which the first participant was enrolled.

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).

Official TitleEvaluation of Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage From a Cerebral Aneurysm
NCT02176837
Principal SponsorHope Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

6 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersHemorrhageNervous System DiseasesPathologic ProcessesSubarachnoid HemorrhagePathological Conditions, Signs and SymptomsVascular DiseasesIntracranial Hemorrhages

Criteria

4 inclusion criteria required to participate
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.
11 exclusion criteria prevent from participating
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;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Virginia Medical Center

Charlottesville, United StatesOpen University of Virginia Medical Center in Google Maps
SuspendedOne Study Center