Long Term Effects of Erythrocyte Lysis
Completed
Conditions studied: Sickle Cell Disease, Hemolytic Anemia
In brief
In this prospective observational trial, participants with chronic hemolysis will be assessed with echocardiogram for elevated tricuspid jet velocity and other evidence of pulmonary hypertension. Participants will have laboratory studies evaluating: severity of hemolysis, splenic function, inflammation, endothelial dysfunction, and hypercoagulability. There will be 3 main categories of participants enrolled in this study: (1) pediatric participants with severe sickle cell disease (SCD) (HbSS, HbS/β° thalassemia ) who are not receiving treatment (e.g., hydroxyurea or chronic transfusions); (2) pediatric participants with other forms of SCD or severe SCD (HbSS, HbS/β° thalassemia) patients being treated with hydroxyurea or chronic transfusions; and (3) pediatric and adult participants with other non-sickling hematological disorders.
Key facts
- Study ID
- NCT00842621
- Run by
- St. Jude Children's Research Hospital
- People needed
- 390
- Starts
- 2009-03-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-06-27
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Established Diagnosis of Hemolysis
- Sickle Cell Disease (e.g., HbSS, HbS/β-thalassemia, HbSC)
- Other conditions with hemolysis (e.g., RBC membranopathies, enzymopathies, unstable hemoglobinopathies, PNH)
- Age
- SCD participants: 5 years of age up to 19th birthday
- All other participants: 5 years of age and up (no age limit)
You may not qualify if…
- Previous cardiac surgery
- Known left ventricle dysfunction (i.e. shortening fraction < 28%)
- Known right sided congenital heart defect such as atrial septal defect or pulmonary valve stenosis
Where it is running
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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