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

NCT ID: NCT02444572

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2020-07-10

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.

Conditions

Gastrointestinal Neoplasms; Thromboembolic Event

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Enoxaparin 4000 IU

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Enoxaparin 4000 IU

Intervention Type: DRUG

Interventions

Enoxaparin 4000 IU

Intervention Type: DRUG

Other Intervention Names

ENOXA®; LOVENOX®

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Les Laboratoires des Médicaments Stériles

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chadli DZIRI, MD

Role: PRINCIPAL_INVESTIGATOR

Charles Nicolle Hospital

Locations

Charles Nicolle Hospital

Tunis, Tunis BAB Souika, Tunisia

Countries

Tunisia

References

Dziri C, Ben Hmida W, Dougaz W, Khalfallah M, Samaali I, Jerraya H, Bouasker I, Nouira R. Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. PLoS One. 2023 Nov 1;18(11):e0293269. doi: 10.1371/journal.pone.0293269. eCollection 2023.

Reference Type: DERIVED

PMID: 37910523 (View on PubMed)

Other Identifiers

ENOXACARE_med14

Identifier Type: -

Identifier Source: org_study_id