Status:
WITHDRAWN
A Pilot Study of Chronic Red Blood Cell Transfusion in Sickle Cell Disease-Associated Pulmonary Hypertension
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Duke University
Conditions:
Pulmonary Hypertension
Sickle Cell Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Pulmonary hypertension, a complication associated with an increased risk of death, is common in patients with sickle cell disease. Despite its frequency, there remains no standard treatment for this c...
Detailed Description
As patients with sickle cell disease (SCD) age, recurrent vaso-occlusive episodes lead to progressive end-organ damage. Pulmonary hypertension (PHT) represents an example of such end-organ damage. Pul...
Eligibility Criteria
Inclusion
- diagnosis of sickle cell anemia (HbSS) and HbSbeta0 thalassemia;
- male and female subjects between 18 and 65 years;
- documented PHT, but with pulmonary artery systolic pressures \>/= 45 mmHg (TR jet velocity of \>/= 3.0 m/s) on at least 2 separate visits at least 1 month apart;
- ability to give written informed consent to participate in the study; and
- in non-crisis steady state at time of enrollment
Exclusion
- treatment with epoprostenol (flolan) or similar prostacyclin analog, bosentan or sildenafil (or similar phosphodiesterase 5 inhibitor)
- on chronic anticoagulation
- RBC transfusion in previous 90 days;
- use of hydroxyurea
- multiple red cell alloantibodies that will make transfusion unsafe;
- baseline ferritin level \> 1000 mg/dL
- pregnancy, and/or any condition which in the opinion of investigator might make the subject unsuitable for the study;
- patients with WHO functional class IV
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00850369
Start Date
February 1 2005
End Date
May 1 2011
Last Update
July 29 2013
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