Effects of Nitric Oxide and Nitroglycerin in Patients With Sickle Cell Anemia

Launched by NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER (CC) · Nov 3, 1999

Keywords

ClinConnect Summary

Sickle cell anemia is an autosomal recessive disorder and the most common genetic disease affecting African-Americans. Approximately 0.15% of African-Americans are homozygous for sickle cell disease, and 8% have sickle cell trait. Acute pain crisis and acute chest syndrome (ACS) are common complications of sickle cell anemia. Inhaled nitric oxide (NO) has been proposed as a possible therapy for the ACS. Anecdotally, NO has been described to rapidly improve the hypoxemia and the clinical course of the ACS. Furthermore, a number of recent studies have suggested that NO may have a favorable im...

Gender

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Eligibility criteria

• INCLUSION CRITERIA:
• • Males or females 18 to 65 years of age.
• • Diagnosis of sickle cell disease (electrophoretic documentation of SS homozygosity is required) or identification as a normal volunteer.
• • Hematocrit greater than 18% (with an absolute reticulocyte count greater than 100,000/ml).
• • Hematocrit 18-21% (with an absolute reticulocyte count greater than 100,000/ml): Only 100 ml of blood may be drawn. The study subject may be re-entered in the study after four weeks (with repeat full screening labs).
• EXCLUSION CRITERIA:
• Clinically unstable sickle cell anemia defined by the following:
• • Having greater than two acute pain crises in the last two months; on hydroxyurea or butyrate therapy any time in the last 12 months; or blood transfusion within last three months, or % hemoglobin A greater than 20%.
• • Age less than 18 years or greater than 65 years.
• • Current pregnancy or lactation.
• • Inability to exercise the anterior tibialis muscle.
• • Active cigarette smoker-defined as the inhalation of smoke from any tobacco product in the last one month.
• • Medical conditions: diabetes mellitus; coronary artery disease; peripheral vascular disease; migraine headaches in the last 12 months; history of previous CVA or stroke; or creatinine greater than 1.0 mg/dL.
• • MRI Exclusions: cardiac pacemaker or implantable defibrillator; aneurysm clip; neural stimulator (e.g. TENS-Unit); any type of ear implant; or metal in the eye (e.g. from machining); any implanted device (e.g. insulin pump, drug infusion device); or any metallic foreign body, shrapnel, or bullet.
• • Hematocrit less than or equal to 18 percent: will not be eligible for the study; may return for evaluation at a later date.
• • No aspirin or non-steroidal anti-inflammatory drugs (no NSAIDS and caffeine the day of the study.) Patients on opiates and acetaminophen will not be excluded.
• • Patients taking Viagra will be excluded from the study.