Gastrointestinal Neoplasms, Thromboembolic Event
Conditions
Keywords
Enoxaparin, Immunogenicity
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.
Interventions
DRUGEnoxaparin 4000 IU
Sponsors
Les Laboratoires des Médicaments Stériles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Tunisia
Outcome results
None listed