Back to resultsIntravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage
Primary Purpose
Subarachnoid Hemorrhage
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sodium Nitrite
Sponsored by
About this trial
This is an interventional treatment trial for Subarachnoid Hemorrhage focused on measuring subarachnoid hemorrhage, vasospasm, nitrite, sodium nitrite
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.
Sites / Locations
- University of Virginia Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sodium Nitrite
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02176837
Brief Title
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
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Study Start Date
June 2014 (undefined)
Primary Completion Date
January 15, 2017 (Actual)
Study Completion Date
January 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hope Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage
Keywords
subarachnoid hemorrhage, vasospasm, nitrite, sodium nitrite
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sodium Nitrite
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Sodium Nitrite
Other Intervention Name(s)
Sodium Nitrite Injection 300 mg/10 mL
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cerebral Vasospasm
Description
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.
Time Frame
180 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenny Liu, MD
Organizational Affiliation
University of Virginia Medical Center, Department of Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage
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