Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial (STArT)

  • STATUS
    Recruiting
  • End date
    Apr 24, 2027
  • participants needed
    360
  • sponsor
    Emory University
Updated on 24 March 2022
opioid
arginine

Summary

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.

Description

The trial is designed as a double-blind, placebo controlled, randomized, phase 3, multi-center trial of IV arginine therapy in children with Vaso-occlusive painful episodes (VOE) in sickle cell disease (SCD) to further knowledge on efficacy and safety of the therapy. The exploratory objective is to more fully characterize the arginine metabolome in children with SCD during VOE, and evaluate the effects of arginine therapy on global arginine bioavailability and mitochondrial function together with important clinical outcomes (time to VOE resolution, pain scores, total parenteral opioid use, Patient-Reported Outcomes (PROs), and hospital length of stay in children with SCD and VOE.

Details
Condition Sickle Cell Disease
Treatment Normal saline, Arginine hydrochloride
Clinical Study IdentifierNCT04839354
SponsorEmory University
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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