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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Thromboembolic Events in Patients Undergoing Gastrointestinal Cancer Surgery and Thromboprophylactic Treatment With Two Enoxaparin Formulations (ENOXA® vs Lovenox®)

Conditions
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Gastrointestinal Neoplasms, Thromboembolic Event

Intervention / Treatment
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* Drug: Enoxaparin 4000 IU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENOXA® group<br>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 | Drug: Enoxaparin 4000 IU<br> <br> * Other names: LOVENOX®;|
| Active Comparator: LOVENOX® group<br>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 | Drug: Enoxaparin 4000 IU<br> <br> * Other names: LOVENOX®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 7 - 10 days postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of symptomatic thromboembolic events | Compare the incidence of symptomatic DVT and pulmonary embolism (PE) between the two study treatment arms | 30 days postoperative | 
| Number of adverse events | To compare the safety of both the study of products | 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 | 0 -10 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Enoxaparin, Immunogenicity