Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®
Status:
Completed
Trial end date:
2020-07-10
Target enrollment:
Participant gender:
Summary
Prospective, monocentric, randomized, parallel group, rater-blinded study using two
formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events
(symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and
thromboprophylactic treatment with either Enoxaparin formulations.
The study has a secondary focus as to evaluate the immunogenicity of the two formulations of
Enoxaparin through a subgroup analysis.
Study followup duration is up to 30 days post surgical procedure.