Thromboembolism

Prevention of Blood Clots in Veins After Hip Replacement Surgery

Pharm-Olam was contracted to provide services for a Phase III study that was to be conducted with 26 sites in Russia, Serbia, Bosnia, Latvia, and Lithuania to determine optimal dose versus adverse events. The study required 960 global patients of which Pharm-Olam was given a target of 345 patients. Pharm-Olam recruited 400 patients while staying ahead of schedule when the global goal was achieved.

The study required the following outcome measures:

  • VTE rate during hospitalization phase
  • Incidence of clinically relevant bleeding during 7-10 days hospitalization
  • Deep vein thrombosis (DVT) during hospitalization phase
  • Symptomatic VTE
  • Rate of total VTE