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Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage

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ClinicalTrials.gov Identifier: NCT02176837
Recruitment Status : Terminated
First Posted : June 27, 2014
Results First Posted : February 8, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hope Pharmaceuticals

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.

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

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Intravenous Nitrite Infusion for Reversal of Cerebral Vasospasm After Subarachnoid Hemorrhage From a Cerebral Aneurysm
Study Start Date : June 2014
Actual Primary Completion Date : January 15, 2017
Actual Study Completion Date : January 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Sodium Nitrite
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).
Drug: Sodium 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.
Other Name: Sodium Nitrite Injection 300 mg/10 mL




Primary Outcome Measures :
  1. Cerebral Vasospasm [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02176837


Locations
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United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Hope Pharmaceuticals
Investigators
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Principal Investigator: Kenny Liu, MD University of Virginia Medical Center, Department of Neurosurgery

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Responsible Party: Hope Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02176837     History of Changes
Other Study ID Numbers: SN-03-01
First Posted: June 27, 2014    Key Record Dates
Results First Posted: February 8, 2018
Last Update Posted: March 30, 2018
Last Verified: March 2018
Keywords provided by Hope Pharmaceuticals:
subarachnoid hemorrhage
vasospasm
nitrite
sodium nitrite
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Vasospasm, Intracranial
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases