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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
168
Charles Nicolle Hospital
Tunis, Tunis BAB Souika, Tunisia
Incidence of asymptomatic Deep Venous Thrombosis (DVT)
To compare the incidence of asymptomatic DVT, assessed by Echo Doppler of the lower limbs, between the two study treatment arms
Time frame: 7 - 10 days postoperative
Incidence of symptomatic thromboembolic events
Compare the incidence of symptomatic DVT and pulmonary embolism (PE) between the two study treatment arms
Time frame: 30 days postoperative
Number of adverse events
To compare the safety of both the study of products
Time frame: 30 days postoperative
Incidence of both Enoxaparin formulations immunogenicity
To compare the levels of platelet factor 4 (PF4)-Heparin complex antibodies an platelet count between the two study treatment arms
Time frame: 0 -10 days postoperative
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