FLOCOR IN PATIENTS WITH SICKLE CELL DISEASE CRISIS

Johns Hopkins University, Baltimore MD

Investigators

Linked publications & trials

Abstract

Abstract: An Open-Label, Safety Extension of Repeated Administration of FLOCOR (Purified Poloxamer 188) to Patients with Sickle Cell Disease in Vaso-Occlusive Crises This is a multi-center study designed to assess the safety and tolerability of repeated exposure to FLOCOR in patients with sickle cell disease. A total of 30 eligible patients will be enrolled at the time of presentation to a health care facility for management of a vaso-occlusive crisis. Patients will receive a 1-hour loading dose of FLOCOR followed by a 47-hour continuous infusion of the drug. At the same time, patients will receive routine hydration and pain management, as required by their clinical condition. After the treatment phase, patients will be monitored for 24 hours or until their crisis resolves for safety, tolerability, and sickle cell related events. One follow-up will be performed 7-14 days after the completion of treatment. Patients will receive a maximum of six courses of FLOCOR within a period of one year from enrollment on this study. Data will be examined for potential indications of increased toxicity with consecutive treatments.