RightFit
RecruitingPhase 1 / Phase 2

Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease

Arginine Therapy for the Treatment of Vaso-Occlusive Events in Children With Severe Sickle Cell Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
7 Years to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether extra arginine can reduce pain, the need for pain medicine, or time spent in the hospital or emergency room. It is for people ages 7–21 with certain types of sickle cell disease who need strong pain medicine for a pain episode caused by blocked blood flow.

The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have sickle cell disease of the Hb-SS or Sβ⁰-thalassemia type.
  • Be 7–21 years old.
  • Weigh at least 25 kg (55 pounds).
  • Need care in an emergency room, hospital, day hospital, or clinic for sickle cell pain that requires opioid pain medicine given by injection or through a vein.

Who can't join

  • The care team has decided to send you home.
  • Have a listed excluded blood type: HbSC, Hb-Beta Thal, HbSD, HbSE, HbSO, or Hb AS carrier.
  • Have hemoglobin below 5 gm/dL, or need a red blood cell transfusion right away. Hemoglobin is the protein that carries oxygen in blood.
  • Have kidney problems, with creatinine above 1.0 or twice your usual level. Creatinine is a blood test used to check kidney health.
  • Have changes in thinking or nervous system function, or have a current or suspected stroke.
  • Are pregnant or allergic to arginine.
  • Had a hospital stay less than 7 days ago, or used inhaled nitric oxide, sildenafil, or arginine in the last 14 days.
  • The study doctor decides the study is not right for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia * 7-21 years of age * Weight \>= 25kg (55lbs) * Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes. Exclusion Criteria: * Decision to discharge home from acute care setting. * Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease (HbSD), hemoglobin SE disease (HbSE), hemoglobin SO disease (HbSO), hemoglobin AS carrier (Hb AS) * Hemoglobin less than 5 gm/dL * Immediate Red cell transfusion anticipated * Renal dysfunction: Creatinine \>1.0 or 2 x baseline * Mental status or neurological changes * Acute stroke or clinical concern for stroke * Pregnancy * Allergy to arginine * Previous hospitalization \< 7 days * Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days * Not an appropriate candidate in the investigator's judgement

Study sites (2)

GA