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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the study is to examine the safety of a 14 day infusion of sodium nitrite, and to study the pharmacokinetics of nitrite, during a 14 day infusion in patients with ruptured cerebral aneurysms.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Drug: Sodium nitrite Drug: Saline Phase 2

Detailed Description:

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 Design

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
Primary Completion Date : November 2010
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Nitrite
Continuous intravenous infusion of Sodium Nitrite
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
Placebo Comparator: Vehicle control
Continuous intravenous infusion of saline
Drug: Saline
14 day continuous infusion of a vehicle control infusion
Other Name: Sterile saline


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Safety of a 14 Day Infusion of Sodium Nitrite [ Time Frame: 14 days ]
  2. Efficacy of 14 Day Infusion of Sodium Nitrite [ Time Frame: 14 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ruptured cerebral aneurysm

Exclusion Criteria:

  • Pregnancy, sickle cell disease, G6PD deficiency, anticoagulant therapy
Contacts and Locations

Information from the National Library of Medicine

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


Locations
United States, Virginia
University of Virginia Health System Medical Center
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Hope Pharmaceuticals
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Edward Oldfield, MD University of Virginia
More Information

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