The trial of IV arginine therapy in children with Vaso-occlusive painful episodes (VOE) in sickle cell disease (SCD) is designed to further knowledge on efficacy and safety of the therapy.
Claudia Morris, MD | |
404-785-7141 | |
[email protected] |
3 Years - 21 Years
Phase 3
Interventional
All
Drug
Other
Age 3-21 years of age, inclusive; AND
Established diagnosis of sickle cell disease (any genotype); AND
Pain requiring medical care in an acute care setting (ED, hospital ward, day hospital, clinic) not attributable to non-sickle cell causes, treated with parenteral opioids.
Responds to 2 doses of IV opioids sufficiently for outpatient management
Greater than 12 hours from first dose of intravenous opioids to treat current pain in acute care setting
Hemoglobin less than 5 gm/dL or emergent need for red blood cell transfusion for hemodynamically unstable patient; OR
Ketamine use in the emergency department for treatment of VOE; OR
Glutamine within 30 days; OR
New SCD drug use < 3 months (e.g. Hydroxyurea, voxelotor, crizanlizumab, etc) OR
Acute mental status or neurological changes; OR
Acute stroke or clinical concern for stroke; OR
Three or more ED visits for sickle cell related pain receiving parenteral opioids in previous 7 days (not including current ED visit); OR
Hospital discharge within previous 7 days; OR
Hypotension requiring clinical intervention; hemodynamic instability; septic shock; OR
Previous randomization in this arginine phase 3 RCT; OR
Use of inhaled nitric oxide, sildenafil or arginine within the last month; OR
Non-English or non-Spanish speaking; OR
pregnancy; OR
Allergy to arginine; OR
PI/clinical team concerns for compliance/issues that may adversely impact study participation/outcome; OR
Adults 18 years or older who lack medical decision-making capacity to consent