Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial

About the study

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.

Study point of contact

Claudia Morris, MD
404-785-7141
[email protected]

Locations

10 United States sites

Age

3 Years - 21 Years

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Drug

Other

participation requirements

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.

participation restrictions

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

Locations

  • Los Angeles, California, United States, Children's Hospital Los Angeles
  • San Francisco, California, United States, UCSF Benioff Children's Hospital
  • Washington, District of Columbia, United States, Children's National Medical Center
  • Atlanta, Georgia, United States, Children's Healthcare of Atlanta at Hughes Spalding
  • Atlanta, Georgia, United States, Children's Healthcare of Atlanta at Egleston
  • Saint Louis, Missouri, United States, Washington University/St. Louis Children's Hospital
  • Columbus, Ohio, United States, Nationwide Children's Hospital
  • Philadelphia, Pennsylvania, United States, Children's Hospital of Philadelphia
  • Houston, Texas, United States, Texas Children's Hospital/Baylor College of Medicine
  • Wauwatosa, Wisconsin, United States, Medical College of Wisconsin/Wisconsin Children's Hospital
Last updated 2022-01-12