Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises
Anemia, Sickle Cell
About this trial
This is an interventional treatment trial for Anemia, Sickle Cell focused on measuring Blood Flow, Nitric Oxide, Pain Crisis, Sickle Cell Anemia, Vaso-Occlusive Crisis, Sickle Cell Disease, SCD
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- University of Alabama
- Children's Hospital Oakland
- Colorado Sickle Cell Treatement and Research Center
- Howard University Hospital
- Johns Hopkins University
- National Institutes of Health Clinical Center, 9000 Rockville Pike
- Brigham and Women's Hospital
- Childrens Hospital, Boston
- Case Western Reserve University Hospital
- St. Christopher's Hospital for Children
- Childrens Hospital, Pittsburgh
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Inhaled Nitric Oxide
Placebo
Participants receive Inhaled nitric oxide (INO)
Participants receive Nitrogen gas