Clinical trial · Interventional
Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®
Comparison of Thromboembolic Events in Patients Undergoing Gastrointestinal Cancer Surgery and Thromboprophylactic Treatment With Two Enoxaparin Formulations (ENOXA® vs Lovenox®)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Thromboembolic Event | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enoxaparin 4000 IU | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ENOXA® group
- description
- 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
- interventionNames
- Drug: Enoxaparin 4000 IU
- type
- ACTIVE_COMPARATOR
- label
- LOVENOX® group
- description
- 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
- interventionNames
- Drug: Enoxaparin 4000 IU
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDDziri 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. PMID 37910523