| Reshka Mendis, MBBS | |
| 352 277-7781 | |
| [email protected] |
| Claudia Morris, MD | |
| 404-727-5500 | |
| [email protected] |
3 United States sites
3 to 21 Years
Phase 2
Interventional
All
Drug
Other
Unknown
The aim of this study is to determine whether giving extra arginine, a simple amino acid, to
patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful
events (VOE) will decrease pain scores, decrease the need for pain medications or decrease
length of hospital stay or emergency department visit. Funding Source – FDA OOPD.
– Established diagnosis of sickle cell disease (SCD); all genotypes
– Pain requiring medical care in an acute care setting (such as the emergency department
or ED, hospital ward, day hospital, clinic) not attributable to non-sickle cell
causes, that is moderate-to-severe requiring parenteral opioids
– Decision to discharge home from the acute care setting
– Hemoglobin less than 5 gm/dL or immediate need for red cell transfusion anticipated
within next 12 hours
– Hepatic dysfunction of SGPT greater than 3 times the upper value
– Renal dysfunction of creatinine greater than 1.0
– Mental status or neurological changes
– Acute stroke or clinical concern for stroke
– Pregnancy
– Allergy to arginine
– Two (2) or more ED visits for VOE within the last 7 days prior to CURRENT ED visit
– Hospitalization within 14 days
– Previous randomization in this arginine RCT (patient consented and screen failed
before receiving study drug or placebo remains eligible for future participation).
– Use of inhaled nitric oxide, sildenafil or arginine within the last month
– PICU admission from the emergency department
– Hypotension requiring treatment with clinical intervention
– Acidosis with Co2≤ 16
– Newly started on HU for <3 months - Not an appropriate candidate in the investigator's judgment - Patient refusal