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

Phase 4

Completed

• Conditions: Gastrointestinal Neoplasms; Thromboembolic Event
• Interventions: Drug: Enoxaparin 4000 IU

• Registration Number: NCT02444572
• Lead Sponsor: Les Laboratoires des Médicaments Stériles

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-14
• Study Start: 2015-10
• Primary Completion: 2020-07
• Study Completion: 2020-07-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ENOXA® group	Enoxaparin 4000 IU	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	Enoxaparin 4000 IU	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

Primary Outcome Measures

Name	Time	Method
Incidence of asymptomatic Deep Venous Thrombosis (DVT)	7 - 10 days postoperative	To compare the incidence of asymptomatic DVT, assessed by Echo Doppler of the lower limbs, between the two study treatment arms

Secondary Outcome Measures

Name	Time	Method
Incidence of symptomatic thromboembolic events	30 days postoperative	Compare the incidence of symptomatic DVT and pulmonary embolism (PE) between the two study treatment arms
Number of adverse events	30 days postoperative	To compare the safety of both the study of products
Incidence of both Enoxaparin formulations immunogenicity	0 -10 days postoperative	To compare the levels of platelet factor 4 (PF4)-Heparin complex antibodies an platelet count between the two study treatment arms

Trial Locations

Locations (1)

Charles Nicolle Hospital; 🇹🇳 Tunis, Tunis BAB Souika, Tunisia