Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®

• Status: Completed
• Trial end date: 2020-07-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Les Laboratoires des Médicaments Stériles
• Treatments: Enoxaparin

Criteria

Inclusion Criteria:

• Male or female over 18 years

• Gastrointestinal (GI) Cancer

• Elective or emergency surgery

• Preventive administration of enoxaparin sodium

Exclusion Criteria:

• Patients participating in another study

• Unfractionated heparin (UFH) use up to 30 days prior to surgical procedure

• Renal failure with creatinine clearance <30 ml / min

• Known history of peripheral venous thrombosis and/or deep venous thrombosis in the 3 months prior to inclusion

• Pregnant or breastfeeding women or women of childbearing age not using medically accepted contraceptive method

• Anticoagulant use in the 3 months prior to inclusion

• Patients with known haemostatic disorder

• Patients not consenting to participate in the study, or not capable of understanding its objectives