Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial

Study point of contact

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

Locations

10 United States sites

Age

3 to 21 Years

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Drug

Other

Compensation

Unknown

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.

participation requirements

1. Age 3-21 years of age, inclusive; AND

2. Established diagnosis of sickle cell disease (any genotype); AND

3. 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

1. Responds to 2 doses of IV opioids sufficiently for outpatient management

2. Greater than 12 hours from first dose of intravenous opioids to treat current pain in
acute care setting

3. Hemoglobin less than 5 gm/dL or emergent need for red blood cell transfusion for
hemodynamically unstable patient; OR

4. Ketamine use in the emergency department for treatment of VOE; OR

5. Glutamine within 30 days; OR

6. New SCD drug use < 3 months (e.g. Hydroxyurea, voxelotor, crizanlizumab, etc) OR 7. Acute mental status or neurological changes; OR 8. Acute stroke or clinical concern for stroke; OR 9. Three or more ED visits for sickle cell related pain receiving parenteral opioids in previous 7 days (not including current ED visit); OR 10. Hospital discharge within previous 7 days; OR 11. Hypotension requiring clinical intervention; hemodynamic instability; septic shock; OR 12. Previous randomization in this arginine phase 3 RCT; OR 13. Use of inhaled nitric oxide, sildenafil or arginine within the last month; OR 14. Non-English or non-Spanish speaking; OR 15. pregnancy; OR 16. Allergy to arginine; OR 17. PI/clinical team concerns for compliance/issues that may adversely impact study participation/outcome; OR 18. Adults 18 years or older who lack medical decision-making capacity to consent

Locations

  • Los Angeles, California, United States, Children's Hospital Los Angeles, 90027
  • San Francisco, California, United States, UCSF Benioff Children's Hospital, 94158
  • Washington, District of Columbia, United States, Children's National Medical Center, 20010
  • Atlanta, Georgia, United States, Children's Healthcare of Atlanta at Hughes Spalding, 03322
  • Atlanta, Georgia, United States, Children's Healthcare of Atlanta at Egleston, 30322
  • Saint Louis, Missouri, United States, Washington University/St. Louis Children's Hospital, 63110
  • Columbus, Ohio, United States, Nationwide Children's Hospital, 43205
  • Philadelphia, Pennsylvania, United States, Children's Hospital of Philadelphia, 19104
  • Houston, Texas, United States, Texas Children's Hospital/Baylor College of Medicine, 77030
  • Wauwatosa, Wisconsin, United States, Medical College of Wisconsin/Wisconsin Children's Hospital, 53226