At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of sickle cell disease: SS, S-Beta-thalassemia, or other hemoglobinopathies causing sickle cell disease (excluding Hgb SC)
- ✓Present to ED/EC or other appropriate unit in vaso-occlusive crisis
- ✓Age ≥10 years
- ✓Written informed consent/assent obtained
- ✕Exposure to therapeutic nitric oxide within past 12 hours
- ✕Recent use of sildenafil, other PDE5 inhibitors, therapeutic L-arginine, nitroprusside, or nitroglycerine within past 12 hours
- ✕ED/EC treatment for VOC within 48 hours or hospitalization within 14 days (unless directly transferred from another ED/clinic)
- ✕More than 10 ED/EC visits in past year for vaso-occlusive crisis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Nitric Oxide for Inhalation in the Acute Treatment of Sickle Cell Pain Crisis
In Brief
A Phase 2 clinical trial evaluating Nitric Oxide and Placebo for Anemia, Sickle Cell. Completed, enrolled 150 participants across 11 sites.
Detailed 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, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transported from the lungs by hemoglobin in red blood cells. Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or other blood problems causing sickle cell disease) may be eligible for this study. Patients whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood tests and a chest x-ray to look at the lungs and heart. Participants are admitted to the hospital in a pain crisis. They are evaluated and then randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2) standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes up most of the air we breathe and is not known to help in sickle cell disease. For the first 8 hours of the study, patients receive placebo or NO through a facemask. The mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic tubing that rests under the nose) that may be taken off only while showering or using the restroom. Patients are questioned about the severity of their pain when they start the study and then every few hours while they are in the hospital. Their vital signs (temperature, breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go home. Patients are followed up about 1 month after starting the study by a return visit to the hospital or by a phone call.
Study Details
Timeline
Interventions
Nitric oxide will be delivered for 4 hours at 80 ppm through a face mask. The dose will then be reduced to 40 ppm for 4 hours. After a total of 8 hours of treatment through face mask, the patient will get 6 mL/puls/breath of NO at 800 ppm or 3 m//pulse/breath, depending on patient weight.
Nitrogen gas will be delivered in the same manor as the experimental drug.