Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT06989567
Eligibility Criteria:
Inclusion Criteria:
* SCD (all genotypes)
* Children, adolescents and young adults between ages 6 to 21 years
* In a steady disease state and not in the midst of any acute complication other than VOC due to SCD at study entry
* Baseline NRS score \>5 or Faces Pain Scale score ≥6
* For females of childbearing potential, a negative urine pregnancy test and using an adequate method of contraception including abstinence
* Patients or parents or legal guardian of the patient who are willing and able to sign and provide consent and assent (where appropriate for the age of the child)
* Patients willing to begin study treatment within 120 minutes after providing informed consent/assent and soon after the first/initial dose, but before any subsequent doses of IV opioid or ketamine
Exclusion Criteria:
* Current pain lasting \>3 days
* History of 9 hospital admissions in the prior year
* Participation in a clinical trial of a new therapy for SCD within the last 1 month
* Presence of any other complication related to SCD such as splenic sequestration, hepatic sequestration, stroke, avascular necrosis of the hip/shoulder, acute priapism, acute renal dysfunction, acute chest syndrome and other major medical conditions or organ dysfunction
* Hypotension requiring clinical intervention; hemodynamic instability; septic shock
* Severe anemia (hemoglobin \<6 g/dL)
* Systemic steroid therapy within the last 24 hours
* Use of inhaled NO or medications that are known to cause hypotension (e.g., nitrates, sildenafil, tadalafil, vardenafil, osildenafil, or arginine) within the last 30 days
* Serum creatinine levels:
* Age 6-13 years: \>0.9 mg/dL
* Age 14-17 years: \>1.0 mg/dL
* Age ≥18 years: \>1.5 mg/dL
* Report of fever (\>38°C) within the last 24 hours
* Presence of acute chest syndrome, sepsis, known bacterial infection, or hemodynamic instability
* Acute mental status or neurological changes
* Acute stroke or clinical concern for stroke
* Patients with inability to have assent given (ages 6 to 17 years) or consent (ages 18 through 21 years).
Note: Parents or legal guardians can provide consent for patients who are unable to provide assent (e.g., sleepy or preoccupied by their pain).
* History of allergic reaction to L-citrulline product or dextrose
* Unreliable venous access
* The PI considers that the patient will be unable to comply with the study requirements
* Patients pre-planned for admission on arrival in ED
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
21 Years
Study:
NCT06989567
Study Brief:
Protocol Section:
NCT06989567