Status:
COMPLETED
Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial
Lead Sponsor:
Claudia R. Morris
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
3-21 years
Phase:
PHASE3
Brief Summary
The trial is designed to test intravenous (IV) arginine therapy in children with sickle cell disease (SCD) and vaso-occlusive painful episodes (VOE) to further knowledge on efficacy and safety of this...
Detailed Description
Pain is a clinical hallmark of sickle cell disease (SCD), and a significant problem in emergency medicine. Vaso-occlusive painful episodes (VOE) are common, debilitating, and a medical emergency. VOE ...
Eligibility Criteria
Inclusion
- Age 3-21 years of age, inclusive
- Established diagnosis of sickle cell disease (any genotype)
- Pain requiring medical care in an acute care setting (emergency department, hospital ward, day hospital, clinic) not attributable to non-sickle cell causes, treated with parenteral opioids
Exclusion
- 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
- Ketamine use in the emergency department for treatment of VOE
- Glutamine within 30 days
- New SCD drug use \< 3 months (e.g. Hydroxyurea, voxelotor, crizanlizumab, etc)
- Acute mental status or neurological changes
- Acute stroke or clinical concern for stroke
- Three or more ED visits for sickle cell related pain receiving parenteral opioids in previous 7 days (not including current emergency department visit)
- Hospital discharge within previous 7 days
- Hypotension requiring clinical intervention; hemodynamic instability; septic shock
- Previous randomization in this arginine phase 3 randomized controlled trial
- Use of inhaled nitric oxide, sildenafil or arginine within the last month
- Non-English speaking or requires a translator for clinical care
- Pregnancy
- Allergy to arginine
- PI/clinical team concerns for compliance/issues that may adversely impact study participation/outcome
- Adults 18 years or older who lack medical decision-making capacity to consent
Key Trial Info
Start Date :
June 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2024
Estimated Enrollment :
271 Patients enrolled
Trial Details
Trial ID
NCT04839354
Start Date
June 21 2021
End Date
July 11 2024
Last Update
July 30 2025
Active Locations (10)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94158
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
Children's Healthcare of Atlanta at Hughes Spalding
Atlanta, Georgia, United States, 03322