Study Detail

Study ID 1024
Name Comprehensive Sickle Cell Centers' (CSCC) -Dexamethasone
Contact Email
Acronym CSCC-Dexamethasone
Period 2006 - 2008
Design Clinical Trial
Study PI Charles Quinn
Institution Children's Hospital Medical Center, Cincinnati
Funding Agency NHLBI
Overview This study tests the effectiveness of oral dexamethasone for the acute chest syndrome (ACS) of sickle cell disease (SCD) in children and adults in the context of standard supportive care. This study primarily aims to determine whether dexamethasone shortens the duration of signs and symptoms of and medical intervention for ACS.
Focus Areas 1. To determine whether dexamethasone decreases the duration of signs and symptoms of ACS.
2. To determine (1) whether dexamethasone reduces morbidity associated with ACS; (2) whether a tapered regimen of dexamethasone prevents rebound VOC; (3) whether dexamethasone modulates the endothelial phenotype to a less proadhesive, and procoagulant state, and to determine if the discontinuation of dexamethasone will be associated with a rebound in the expression of endothelial activation markers of adhesion and coagulation; (4) whether dexamethasone prevents subacute adverse effects of ACS on pulmonary function; and (5) whether dexamethasone modulates white cell activation and if the discontinuation of dexamethasone will be associated with a rebound in white cell activation.
Outcomes 1. The duration of signs and symptoms of ACS or duration of hospitalization, whichever is less. The duration of signs and symptoms of ACS is defined as the interval between study entry and the time at which tachypnea, hypoxemia, increased work of breathing, and thoracic pain have resolved and supplemental oxygen and ventilatory support are no longer utilized.
2. Clinical endpoints include: rating of pain, duration of hospitalization, supplemental oxygen, hypoxemia, and fever, number of transfusions, quantification of opioid use, rebound hospitalizations, pulmonary radiographic findings, and pulmonary function testing results. Laboratory endpoints include: VCAM1, ICAM1, P-selectin, L-selectin, vWF multimers, endothelial and monocyte microparticles, WBTF, NO, and sPLA2.
Data Location RTI International
Biospecimen Available Blood; Plasma; Serum; Urine; Cell;
Data Consent Data from the trial are confidential and may not be disclosed without the written permission of the NHLBI; consent includes statement regarding data deidentification.
Biospecimen Consent NA
Contact Consent NA
Genomic Data No
Age Range 5-99
No. Participants 12
Inclusion Criteria New episode of ACS; diagnosis of ACS within preceding 24 hours; and provision of informed consent.
Exclusion Criteria Prior participation in this study; corticosteroids contraindicated for comorbid conditions; corticosteroid treatment in preceding 2 weeks.
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