Without these clinical trails and research, innovative discoveries within the medical field would not make it to the patients that will benefit from them.
Takeda Factor Xa Reversal Study
The Takeda drug trial is an IRB approved, phase 3, prospective, randomized, open-label, adaptive group sequential, multicenter trial focused on evaluating the efficacy and safety of PROTHROMPLEX TOTAL, a reversal agent of factor Xa inhibitors (blood thinners), for patients requiring urgent surgery. Factor Xa inhibitors (blood thinners) are used to prevent blood clots and treat other cardiovascular conditions but can increase bleeding during surgery and other surgical complications. Patient's using these medications directly before urgent surgery require a reversal medication, such as PROTHROMPLEX TOTAL, to counteract these effects. This study aims analyze the efficacy and safety of this medication compared to 4-factor prothrombin complex concentrate (4F-PCC), a similar Factor Xa Inhibitor reversal agent already used in hospitals across the United States. It is a 4-week participating study consisting of an initial hospital visit and surgery as well as one follow-up phone conversation with a Denver Metro Orthopedics, P.C. study coordinator.
For any questions regarding research conduct or participation, please call Denver Metro Orthopedics, P.C., or reserve an appointment online today.