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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:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Hope Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Subarachnoid Hemorrhage
Interventions Drug: Sodium nitrite
Drug: Saline
Enrollment 19
Recruitment Details Patients admitted to University of Virginia Medical Center for the treatment of subarachnoid hemorrhage were screened for possible recruitment into this study.
Pre-assignment Details Patients underwent neurosurgical repair of their subarachnoid hemorrhage prior to study recruitment and assignment.
Arm/Group Title Vehicle Control Nitrite 32 Nmol/Min/kg Nitrite 48 Nmol/Min/kg Nitrite 64 Nmol/Min/kg
Hide Arm/Group Description Nitrite : 14 day continuous infusion of a vehicle control infusion 14 day continuous infusion of sodium nitrite 32 nmol/min/kg 14 day continuous infusion of sodium nitrite 48 nmol/min/kg 14 day continuous infusion of sodium nitrite 64 nmol/min/kg
Period Title: Overall Study
Started 9 4 3 3
Completed 9 3 3 3
Not Completed 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0
Arm/Group Title 32 Nmol/Min/kg Vehicle Control 48 Nmol/Min/kg 64 Nmol/Min/kg Total
Hide Arm/Group Description Sodium nitrite : 14 day continuous infusion 32 nmol/min/kg Nitrite : 14 day continuous infusion of a vehicle control infusion Sodium nitrite: 14 day continuous infusion 48 nmol/min/kg Sodium nitrite: 14 day continuous infusion 64 nmol/min/kg Total of all reporting groups
Overall Number of Baseline Participants 4 9 3 3 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 9 participants 3 participants 3 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
8
  88.9%
3
 100.0%
3
 100.0%
18
  94.7%
>=65 years
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
1
   5.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 9 participants 3 participants 3 participants 19 participants
50  (10) 52  (18.3) 50  (5) 58  (7) 51  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 9 participants 3 participants 3 participants 19 participants
Female
3
  75.0%
6
  66.7%
2
  66.7%
2
  66.7%
13
  68.4%
Male
1
  25.0%
3
  33.3%
1
  33.3%
1
  33.3%
6
  31.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 9 participants 3 participants 3 participants 19 participants
4 9 3 3 19
1.Primary Outcome
Title Mean Plasma Nitrite Concentration (Micromol/L)
Hide Description 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.
Time Frame multiple time points up to the end of day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol
Arm/Group Title 64 Nmol/Min/kg 48 Nmol/Min/kg 32 Nmol/Min/kg
Hide Arm/Group Description:
Sodium nitrite : 14 day continuous infusion of 64 nmol/min/kg
Sodium nitrite : 14 day continuous infusion of 48 nmol/min/kg
Sodium nitrite : 14 day continuous infusion of 32 nmol/min/kg
Overall Number of Participants Analyzed 3 3 3
Mean (Standard Deviation)
Unit of Measure: micromol/L
4.2  (0.3) 4.3  (0.4) 2.6  (0.3)
2.Secondary Outcome
Title Safety of a 14 Day Infusion of Sodium Nitrite
Hide Description [Not Specified]
Time Frame 14 days
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Efficacy of 14 Day Infusion of Sodium Nitrite
Hide Description [Not Specified]
Time Frame 14 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nitrite Vehicle Control
Hide Arm/Group Description 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 Nitrite : 14 day continuous infusion of a vehicle control infusion
All-Cause Mortality
Nitrite Vehicle Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Nitrite Vehicle Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      2/9 (22.22%)    
Infections and infestations     
Abscess  [1]  0/9 (0.00%)  0 1/9 (11.11%)  1
Nervous system disorders     
Death  [2]  0/9 (0.00%)  0 1/9 (11.11%)  1
Indicates events were collected by systematic assessment
[1]
Abdominal abscess (secondary to percutaneous endoscopic gastrostomy tube dislodgement)
[2]
Stroke progression (withdrawal of life support)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nitrite Vehicle Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Edward Oldfield
Organization: University of Virginia Medical Center
Phone: (434) 982-0059
Responsible Party: Hope Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00873015     History of Changes
Other Study ID Numbers: 14024
1R44NS063485-01 ( U.S. NIH Grant/Contract )
First Submitted: March 31, 2009
First Posted: April 1, 2009
Results First Submitted: January 26, 2013
Results First Posted: July 16, 2013
Last Update Posted: June 7, 2017