| Claudia Morris, MD | |
| 404 727-5500 | |
| [email protected] |
| Reshika Mendis, MBBS | |
| 404-785-4525 | |
| [email protected] |
2 United States sites
7 to 21 Years
SS
Phase 1/Phase 2
Interventional
All
Drug
Unknown
The purpose of this study is to determine whether giving extra arginine to patients with
sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease
pain scores, decrease need for pain medications or decrease length of hospital stay or
emergency department visit.
– Established diagnosis of sickle cell disease–Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
– 7-21 years of age
– Weight >= 25kg (55lbs)
– Pain requiring medical care in an acute care setting (emergency department (ED),
hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to
non-sickle cell causes.
– Decision to discharge home from acute care setting.
– Diagnosis of sickle cell disease with any of the following types: hemoglobin SC
disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease
(HbSD), hemoglobin SE disease (HbSE), hemoglobin SO disease (HbSO), hemoglobin AS
carrier (Hb AS)
– Hemoglobin less than 5 gm/dL
– Immediate Red cell transfusion anticipated
– Hepatic dysfunction: serum glutamic pyruvic transaminase (SGPT) > 3X upper value
– Renal dysfunction: Creatinine >1.0 or 2 x baseline
– Mental status or neurological changes
– Acute stroke or clinical concern for stroke
– Pregnancy
– Allergy to arginine
– Previous hospitalization < 7 days - Previous randomization in this arginine pK study (patient consented and screened failed before receiving study drug or placebo remains eligible for future participation) - Use of inhaled nitric oxide, sildenafil or arginine within the last month