RECRUITING

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

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Conditions

Sickle Cell Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2015-05
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02447874

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
  2. * 7-21 years of age
  3. * Weight \>= 25kg (55lbs)
  4. * 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.
  1. * Decision to discharge home from acute care setting.
  2. * 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)
  3. * Hemoglobin less than 5 gm/dL
  4. * Immediate Red cell transfusion anticipated
  5. * Renal dysfunction: Creatinine \>1.0 or 2 x baseline
  6. * Mental status or neurological changes
  7. * Acute stroke or clinical concern for stroke
  8. * Pregnancy
  9. * Allergy to arginine
  10. * Previous hospitalization \< 7 days
  11. * Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days
  12. * Not an appropriate candidate in the investigator's judgement

Contacts and Locations

Study Contact

Reshika Mendis, MBBS
CONTACT
404-785-4525
Reshika.mendis@choa.org
Claudia Morris, MD
CONTACT
404 727-5500
claudia.r.morris@emory.edu

Principal Investigator

Claudia Morris, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Children's Healthcare fo Atlanta at Hughes Spalding
Atlanta, Georgia, 30303
United States
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
United States

Collaborators and Investigators

Sponsor: Emory University

  • Claudia Morris, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-05
Study Completion Date2026-07

Study Record Updates

Study Start Date2015-05
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Sickle Cell Disease