Status:
COMPLETED
Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises
Lead Sponsor:
Mallinckrodt
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Anemia, Sickle Cell
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, a...
Detailed Description
The object of this study is to determine the safety and efficacy of nitric oxide for inhalation in the treatment of vaso-occlusive pain crisis (VOC) in patients with sickle cell disease. The study pop...
Eligibility Criteria
Inclusion
- Each subject must meet all of the following inclusion criteria during the screening process in order to participate in the study:
- Patient must have a diagnosis of SCD (known SS, S-Beta-thalassemia or other hemoglobinopathies causing sickle cell disease). Patients with disease due to Hgb SC are not permitted.
- Must present to the ED/EC or other appropriate unit in VOC.
- Greater than or equal to 10 years old.
- Written informed consent/assent has been obtained.
Exclusion
- Subjects meeting any of the following criteria during baseline evaluation will be excluded from entry into the study:
- Exposure to therapeutic nitric oxide within the past 12 hours.
- Patient has received sildenafil or other phosphodiesterase 5 inhibitors, therapeutic L-arginine, nitroprusside or nitroglycerine within the past 12 hours.
- Patient has received previous ED/EC or other appropriate unit treatment for a vaso-occlusive crisis less than 48 hours or hospitalization less than 14 days ago (patients transferred directly from another ED or clinic may be enrolled).
- Patient has visited the ED/EC or other appropriate unit greater than 10 times in the past year having a vaso-occlusive crisis.
- Patients presenting with clinically diagnosed bacterial infection (e.g., osteomyelitis, pneumonia, sepsis or meningitis).
- Patients who are currently enrolled in any other investigational drug study except for hydroxyurea studies.
- Pregnant women (urine HCG + )/ nursing mothers.
- Patients who have received an exchange transfusion (not simple transfusion) in the last 30 days or are on a chronic simple or exchange transfusion program.
- Suspected splenic sequestration.
- Acute chest syndrome or pneumonia: Abnormal new pulmonary infiltrate (alveolar infiltration and not atelectasis) and one or more pulmonary signs and/or symptoms (fever, rales, wheezing, cough, shortness of breath, retractions).
- Previous participation in this study.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00094887
Start Date
October 1 2004
End Date
December 1 2008
Last Update
February 5 2020
Active Locations (11)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
Children's Hospital Oakland
Oakland, California, United States, 94609-1809
3
Colorado Sickle Cell Treatement and Research Center
Aurora, Colorado, United States, 80045
4
Howard University Hospital
Washington D.C., District of Columbia, United States, 20060