Subarachnoid Hemorrhage
Conditions
Keywords
subarachnoid hemorrhage, vasospasm, nitrite, sodium nitrite
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).
Interventions
DRUGSodium 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.
Sponsors
Hope Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sodium Nitrite 64 nmol/min/kg sodium nitrite | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Sodium Nitrite |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: 180 minutes
Population: Patients who received sodium nitrite
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sodium Nitrite | Cerebral Vasospasm | Increased flow between baseline and 2nd radiograph | 2 Participants |
| Sodium Nitrite | Cerebral Vasospasm | Unchanged flow between baseline and 2nd radiograph | 4 Participants |