A Randomized, Controlled, Open Label Study of the Efficacy and Safety of the Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin) Versus HeparinTM (Unfractionated Heparin) for Prevention of Venous Thromboembolism (VTE) in Gynecologic Oncology Patients
This study is a phase IIIB, randomized, open label, non-comparative controlled trial, and
prospectively enrolling 150 females to assess the efficacy and safety of the Enoxaparin
(Group A) and Unfractionated Heparin (Group B) for Gynecologic Oncology Patients In the
Kingdom of Saudi Arabia who required surgery or admission for the prevention of VTE.
Patients who meet the Inclusion Criteria and signed an informed consent will be randomly
assigned to 1 of the 2 treatment groups (Group A or Group B). Subjects will be assigned
consecutive study numbers according to a predetermined random code generated by the
Biostatistician. The randomisation will be based on a 1:1 ratio.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Efficacy will be measured by measuring any thromboembolic events confirmed by objective testing such as spiral CT or V/Q scan and Doppler ultrasound as well as coagulation profile parameter, clinical sign and symptoms within 3 months post-operation.
Faisal Safi, MD
King Abdul Aziz Medical City for National Guard
Saudi Arabia: Ethics Committee