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

Gastrointestinal Neoplasms Clinical Trial

— ENOXACARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444572
• Other study ID #: ENOXACARE_med14
• Status: Completed
• Phase: Phase 4
• Start date: October 2015
• Est. completion date: July 10, 2020

Study information

• Verified date: July 2021
• Source: Les Laboratoires des Médicaments Stériles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: July 10, 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Thromboembolic Event
• Thromboembolism

Intervention

Drug:
• Enoxaparin 4000 IU

Locations

Country	Name	City	State
Tunisia	Charles Nicolle Hospital	Tunis	Tunis BAB Souika

Sponsors (1)

Lead Sponsor	Collaborator
Les Laboratoires des Médicaments Stériles

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of symptomatic thromboembolic events	Compare the incidence of symptomatic DVT and pulmonary embolism (PE) between the two study treatment arms	30 days postoperative
Secondary	Number of adverse events	To compare the safety of both the study of products	30 days postoperative
Secondary	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