E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
VENOUS THROMBOEMBOLIC DISEASE IN PATIENTS UNDERGOING ONCOLOGICAL ABDOMINAL OR PELVIC SURGERY |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10043640 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy and safety of the subcutaneous (sc) administration of Bemiparin (3,500 IU/day) for 284 in comparison with such therapy for 82 in the prevention of venous thromboembolism (VTE) in patients undergoing an oncological abdominal or pelvic surgical operation. |
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E.2.2 | Secondary objectives of the trial |
Exploratory analyses will be carried out to evaluate: 1- The biological effect of the sc. administration of Bemiparin (3,500 IU/day) on different biological markers involved in the tumoral development and its metastasis in patients undergoing an oncological abdominal or pelvic surgical operation.
2- The effect of the sc. administration of Bemiparin (3,500 IU/day) on the evolution of the tumour in patients undergoing an oncological abdominal or pelvic surgical operation.
3- The effect of the sc. Administration of Bemiparin (3,500IU/day) on the survival of the patients at 6 months from operation
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients of 40 years of age or older, of either sex, who have given their informed consent to participate in the study. 2. Patients with a malignant neoplastic process (primary or metastasic) of the gastrointestinal tract (except the oesophagus), genitourinary tract or female reproductive organs, previously diagnosed and documented, and who are programmed to undergo elective, open, curative or palliative surgery directly related to that process. 3. Patients undergoing surgery with general or spinal anaesthesia, with an estimated duration of surgery of over 30 minutes. 4. Patients with a life expectancy of at least 3 months.
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E.4 | Principal exclusion criteria |
1. Curative or palliative surgery of a malignant neoplastic process in liver, biliary tract or pancreas. 2. Women who are pregnant or breast-feeding, or women of child-bearing age who are not using effective contraconceptive methods. 3. Patients with macrohaematuria, active haemorrhage within the past two months, organ lesions at risk of bleeding (e.g. active peptic ulcer, haemorrhagic cerebrovascular accident, aneurysms), a history of episodes of clinically evident haemorrhage, major surgery in the previous month or an increase in the risk of bleeding due to any disturbance of haemostasis which would contraindicate the anticoagulant therapy, with the exception of bleedings episodes directly caused by tumour subjected to the surgical intervention. 4. Patients with known hypersensitivity to the LMWHs, to heparin or to substances of porcine origin. 5. Patients with known hypersensitivity to radiological contrast media. 6. Patients with known hypersensitivity to anaesthetic drugs or pre-anaesthetic drugs. 7. Patients with a congenital or acquired bleeding diathesis (confirmed by haematological test), with or without haematuria. 8. Lesions or surgical interventions of the central nervous system, eyes or ears within the previous 6 months, including hemorrhagic or ischemic cerebro-vascular accident, cerebral thrombosis and/or known cerebral metastasis. 9. Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia. 10. Acute bacterial endocarditis and slow endocarditis. 11. Patients on treatment with oral or parenteral anticoagulants within 5 days before the operation. 12. Patients with a history of thrombocytopenia associated with heparin or with a current platelet count <75,000/ mm3. 13. Patients with severe renal failure (defined as a serum creatinine over 2 mg/dl), hepatic insufficiency (with AST and/or ALT values > 5 times over normal values established by the reference range of the local laboratory of the hospital). 14. Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg). 15. One or more documented episodes of DVT and/or PE, confirmed by a ventilation-perfusion gamma scan or helical CT in the previous 3 months. 16. Patients with suspected or confirmed inability to comply with the study treatment and/or follow-up. 17. Patients who are participating in another clinical trial or who have done so in the past 30 days. 18. Patients with a vena cava filter in place. 19. Patients needing the use of unallowed concomitant treatments or medicaments such as more than 125 mg/day aspirin, NSAIDs with long half-life of significant anti-aggregation activity, metformin, or any anti-coagulant compound (please refer to section of the protocol "Concomitant medications and treatments" for details).
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E.5 End points |
E.5.1 | Primary end point(s) |
The combined incidence of deep venous thrombosis (DVT), pulmonary embolism (PE) and all-cause mortality, during the period of randomised treatment, will be evaluated as the main efficacy variable. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 30 |