PROTECT Phase III Trial
2,200 Patient Phase III Trial Initiated in 2000
Purpose: Evaluate safety and efficacy of liquid oral heparin formulation for DVT prevention following total hip replacement surgery
Goal: Demonstrate superior efficacy and comparable safety of 30 day dosing of liquid heparin vs. 10 day dosing of injectable LOVENOX
Detection Method: Venogram 30 days following surgery
Conclusion: Safe mechanism and carrier, but not ready for “prime time”