IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will be conducted at 15-20 US centers in a randomized, placebo-controlled, double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients at-risk for acute chest syndrome (ACS) based on the presence of vaso-occlusive crisis (VOC), fever (T ≥38.0°C) and serum sPLA2 concentration ≥50 ng/mL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anthera Pharmaceuticals

Criteria

Patients are eligible for inclusion if they meet the following criteria:

• Sickle cell variant (Hb SS, Hb SC, sickle β°-thalassemia, sickle β+-thalassemia)

• Pain consistent with vaso-occlusive crisis

• Elevated serum sPLA2 level (measured on-site)

• Fever

• Age ≥5 years (through adult)

Patients must NOT meet any of the following exclusion criteria:

• New lung infiltrate by chest radiography

• Pregnancy or breastfeeding

• Significant renal dysfunction

• Significant hepatic dysfunction

• Acute neurologic dysfunction

• Any medical condition for which transfusion may be needed imminently, and/or hemoglobin <5 g/dL

• Red blood cell transfusion within 30 days of entry into the study