Clinical Research Directory

Inclusion Criteria: * Any child diagnosed with craniosynostosis in need of surgical repair * Males and females between the ages of 2 - 36 months (minorities will be included) * Surgical procedure involving complex craniofacial reconstruction and craniotomy * Written informed consent from parent/guardian Exclusion Criteria: * Subjects with known or suspected hypersensitivity reaction to Amicar or history of prior Amicar exposure * Presence or prior history of a known coagulation disorder or hypercoagulable state * Preoperative laboratory values that indicate clinically significant hematologic disease (hemoglobin, platelet count, prothrombin time, or partial thromboplastin time outside of normal range) * Subjects who are on anticoagulant therapy (Coumadin, heparin, aspirin, etc.) * Subjects with a prior history of a thrombotic event * History of renal malformation * Presence of hematuria * History of abnormal renal function - serum creatinine or blood urea nitrogen (BUN) value greater than 1.5 times the upper limit of the normal range * Craniofacial reconstruction surgery performed in conjunction with an additional surgical procedure associated with blood loss * Subjects who have been previously enrolled in this protocol may not be enrolled again