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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02444572
Other study ID # ENOXACARE_med14
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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