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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENOXA® group | Experimental | Patients under ENOXA® 4000 IU according to randomization:
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| LOVENOX® group | Active Comparator | Patients under LOVENOX® 4000 IU according to randomization:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin 4000 IU | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic thromboembolic events | Compare the incidence of symptomatic DVT and pulmonary embolism (PE) between the two study treatment arms | 30 days postoperative |
| Number of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chadli DZIRI, MD | Charles Nicolle Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles Nicolle Hospital | Tunis | Tunis BAB Souika | 1006 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37910523 | Derived | 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. |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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To compare the safety of both the study of products
| 30 days postoperative |
| 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 |
| D005767 |
| Gastrointestinal Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002241 |
| Carbohydrates |