๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sฮฒแดผ-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
๐
What it tests
- Arginine
- Arginine (Loading)
- Arginine (Continuous)
Children's Healthcare fo Atlanta at Hughes Spalding
Atlanta, United States
Children's Healthcare of Atlanta at Arthur M. Blank Hospital
Atlanta, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.