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OpenTrials
Completed

NCT Number: NCT02444572

Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With 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.

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Key information

Conditions

Gastrointestinal Neoplasms Cardiovascular Diseases Digestive System Diseases Digestive System Neoplasms Embolism and Thrombosis Gastrointestinal Diseases Neoplasms Neoplasms by Site Thromboembolic Event Thromboembolism Vascular Diseases

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charles Nicolle Hospital

Tunis, Tunis BAB Souika, 1006, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enoxaparin 4000 IU

Drug

Other names: ENOXA®, LOVENOX®

Primary outcomes

  1. Incidence of asymptomatic Deep Venous Thrombosis (DVT)

    Time frame: 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 outcomes

  1. Incidence of symptomatic thromboembolic events

    Time frame: 30 days postoperative

    Compare the incidence of symptomatic DVT and pulmonary embolism (PE) between the two study treatment arms

  2. Number of adverse events

    Time frame: 30 days postoperative

    To compare the safety of both the study of products

  3. Incidence of both Enoxaparin formulations immunogenicity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Les Laboratoires des Médicaments Stériles

Industry

Registry information

Official study title

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

Acronym: ENOXACARE

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 14, 2015
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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