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

L

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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