Howard-Children's National Medical Center Sickle Cell Disease Clinical Center
Principal Investigator: Victor R. Gordeuk, MD
The purpose of this federal grant is to establish a Sickle Cell Disease Clinical Center at Howard University and Children’s National Medical Center in Washington, DC that will also collaborate with the sickle cell disease program at the Clinical Center of the National Institutes of Health in Bethesda, MD. The institutions participating in this Clinical Center follow over 1,000 patients with sickle cell disease (SCD) and enroll more than 100 new patients per year. The objectives of the Howard-CNMC Sickle Cell Clinic Center are as follows.
- To develop the local research infrastructure required for designing and implementing
clinical protocols, primarily clinical trials, as part of a multi-center Network of clinics currently treating a large number of sickle cell patients. The Network's main objective is to advance the management of sickle cell disease (SCD) and other hemoglobinopathies by testing the safety, efficacy and effectiveness of new therapeutic and preventive interventions.
- To propose two multi-center clinical trials as candidate protocols for the Sickle Cell
Network. Both trials will focus on lowering sickle cell complications by improving vascular function. The first trial will determine whether atorvastatin administration prevents vaso-occlusive events (crises, ACS). The second study will examine whether the combination of the NO donors, hydralazine and isosorbide dinitrate, prevent the development of pulmonary hypertension and progression of renal/CNS/systemic vasculopathy in SCD patients who have a relative elevation in systemic systolic blood pressure.
- To help provide comprehensive, state of the art care to children and adults with sickle cell disease (SCD) enrolled in Network clinical protocols. For several decades both, the Howard University Center for Sickle Cell Disease and its proposed collaborating institution, Children’s' National Medical Center (CNMC), have been providing this type of care to a large population of Washington, DC area sickle cell patients. A major feature of both sickle cell programs has always been continuity of care and participation in collaborative research.
- Improving Pain Management and Outcomes with Various Strategies of Patient-Controlled Analgesia (PCA) (IMPROVE). Patient-Controlled Analgesia (PCA) means that the patient is in control of his/her pain medicine. In this study two (2) different treatment plans of Patient-Controlled Analgesia will be used to treat people with sickle cell disease who are admitted to the hospital for a pain crisis. The purpose of this study is to find out if one plan is better than the other in controlling sickle cell pain.
- Preventing Acute Chest Syndrome by Transfusion (PROACTIVE) Feasibility Study. The purpose of this study, which is sponsored by the National Heart, Lung and Blood Institute of the federal government, is to learn whether blood transfusions may prevent ACS when sickle cell patients hospitalized for pain develop an elevated sPLA2 (a blood enzyme). However, in order to learn whether the sPLA2 will be a good test for predicting ACS, and whether enough patients will be available for the full study, the investigators are conducting this Screening (Feasibility) Study.