ProFibrix announced initiation of its Phase 2 study of Fibrocaps for use as a hemostatic agent in surgery. This prospective, randomized, multicenter, single-blind, controlled study will evaluate the efficacy of Fibrocaps, defined as the mean time to hemostasis (TTH) of Fibrocaps versus control, as well as overall safety. The trial will enroll approximately 130 patients, randomized across four different surgical indications: peripheral vascular surgery, spinal surgery, liver resection surgery and soft tissue dissection.
Fibrocaps, a dry powder topical fibrin sealant, is a mixture of fibrinogen and thrombin being developed to stop bleeding during or after surgery. Fibrocaps is ready for immediate use and is stable at room temperature.
For more information call (206) 324-2030 or visit www.profibrix.com.