Safety and Pharmacokinetic Evaluation of Nitrite for Prevention of Cerebral Vasospasm
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ClinicalTrials.gov Identifier: NCT00873015 |
Recruitment Status
:
Completed
First Posted
: April 1, 2009
Results First Posted
: July 16, 2013
Last Update Posted
: June 7, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Subarachnoid Hemorrhage | Drug: Sodium nitrite Drug: Saline | Phase 2 |
Intravenous sodium nitrite has been shown to prevent and to reverse cerebral vasospasm in a primate model of subarachnoid hemorrhage (SAH). This was a Phase IIA dose escalation study of sodium nitrite to determine its safety in patients with aneurysmal SAH and to establish its pharmacokinetics during a 14 day infusion.
Sodium nitrite was delivered intravenously for 14 days in 18 patients with SAH from a ruptured cerebral aneurysm using a dose escalation scheme in three cohorts of 6 patients each (3 nitrite, 3 saline), with a maximum dose of 64 nmol/min/kg. Sodium nitrite blood levels were frequently sampled and measured using mass spectroscopy and blood methemoglobin levels were continuously monitored using a pulse oximeter.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Safety and Pharmacokinetic Evaluation of Sodium Nitrite Injection for the Prevention of Post-Subarachnoid Hemorrhage Induced Vasospasm |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | November 2010 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Nitrite
Continuous intravenous infusion of Sodium Nitrite
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Drug: Sodium nitrite
14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
Other Name: Sodium Nitrite Injection NDC 60267-311-10
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Placebo Comparator: Vehicle control
Continuous intravenous infusion of saline
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Drug: Saline
14 day continuous infusion of a vehicle control infusion
Other Name: Sterile saline
|
- Mean Plasma Nitrite Concentration (Micromol/L) [ Time Frame: multiple time points up to the end of day 14 ]Samples for pharmacokinetic analysis were collected from subjects treated with sodium nitrite at -15, -5, 0, 10, 30, 60, and 90 minutes after starting nitrite infusion and then at 2, 4, 6, 8, 12, 24, and every 24 hours after starting nitrite infusion. The sample at the time of starting the infusion was considered to be the time 0 sample. On study day 14 additional blood samples were collected at 0, 10, 30, 60, and 90 minutes and at 2, 4, 6, 8, and 12 hours after stopping nitrite infusion. Blood samples were analyzed for nitrite levels using mass spectroscopy.
- Safety of a 14 Day Infusion of Sodium Nitrite [ Time Frame: 14 days ]
- Efficacy of 14 Day Infusion of Sodium Nitrite [ Time Frame: 14 days ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ruptured cerebral aneurysm
Exclusion Criteria:
- Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873015
United States, Virginia | |
University of Virginia Health System Medical Center | |
Charlottesville, Virginia, United States, 22903 |
Principal Investigator: | Edward Oldfield, MD | University of Virginia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hope Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00873015 History of Changes |
Other Study ID Numbers: |
14024 1R44NS063485-01 ( U.S. NIH Grant/Contract ) |
First Posted: | April 1, 2009 Key Record Dates |
Results First Posted: | July 16, 2013 |
Last Update Posted: | June 7, 2017 |
Last Verified: | May 2017 |
Keywords provided by Hope Pharmaceuticals:
Cerebral aneurysm Subarachnoid hemorrhage Nitrite |
Additional relevant MeSH terms:
Hemorrhage Subarachnoid Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |