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

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

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 Overview

• Status: Completed
• Conditions: Gastrointestinal Neoplasms; Thromboembolic Event
• Intervention / Treatment: Drug: Enoxaparin 4000 IU

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Tunis BAB Souika
    • Tunis, Tunis BAB Souika, Tunisia, 1006
      • Charles Nicolle Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ENOXA® group; 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; Other Names: ENOXA®; LOVENOX®
Active Comparator: LOVENOX® group; 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; Other Names: ENOXA®; LOVENOX®

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Les Laboratoires des Médicaments Stériles
• Investigators: Principal Investigator: Chadli DZIRI, MD, Charles Nicolle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 10, 2020

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 14, 2015

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Immunogenicity; Enoxaparin
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Embolism and Thrombosis; Gastrointestinal Neoplasms; Digestive System Neoplasms; Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin
• Other Study ID Numbers: ENOXACARE_med14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO