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

Les Laboratoires des Médicaments Stériles

Status and phase: Completed; Phase 4

Conditions: Thromboembolic Event; Gastrointestinal Neoplasms

Treatments: Drug: Enoxaparin 4000 IU

Study type: Interventional

Funder types: Industry

Identifiers

NCT02444572

ENOXACARE_med14

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

ENOXA® group

Experimental group

Description:

Patients under ENOXA® 4000 IU according to randomization: * Administer ENOXA® 4000 IU (Enoxaparin 4000 IU) per day, regardless of the patient's weight at inclusion * Start injections 12 hours after the surgical procedure * Administer ENOXA® subcutaneously * The administration of ENOXA® should be at the same time on a daily basis for 30 successive days as per the american and french clinical guidelines

Treatment:

Drug: Enoxaparin 4000 IU

LOVENOX® group

Active Comparator group

Description:

Patients under LOVENOX® 4000 IU according to randomization: * Administer LOVENOX® 4000 IU (Enoxaparin 4000 IU) per day, regardless of the patient's weight at inclusion * Start injections 12 hours after the surgical procedure * Administer LOVENOX® subcutaneously * The administration of LOVENOX® should be at the same time on a daily basis for 30 successive days as per the american and french clinical guidelines

Treatment:

Drug: Enoxaparin 4000 IU