Trial | NCT02444572  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    enoxaparin ...

  • Study Participants

    168
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 Started
Oct 31
2015
Primary Completion
Jul 31
2020
Study Completion
Jul 10
2020
Last Update
Jul 29
2021

Drug Enoxaparin 4000 IU

  • Other names: ENOXA®, LOVENOX®

ENOXA® group Experimental

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

LOVENOX® group Active Comparator

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

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
No Results Posted