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.
Reshika Mendis, MBBS | |
404-785-4525 | |
[email protected] |
Claudia Morris, MD | |
404 727-5500 | |
[email protected] |
7 Years - 21 Years
Phase 1/Phase 2
Interventional
All
Drug
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
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
Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days
Not an appropriate candidate in the investigator's judgement