Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of the subcutaneous administration for 45 days of Bemiparin (3,500 UI/day) in cancer patients with a CVC, to prevent CVC-related deep venous thrombosis (CVC-DVT)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Collaborator: Laboratorio farmacéutico ROVI
• Treatments: Bemiparin; Heparin, Low-Molecular-Weight

Criteria

Inclusion Criteria:

• Patients over 18 years old of either sex who have given their informed consent to participate in the study.

• Patients with a neoplastic process, with a CVC for the administration of anti-tumoral treatment or any other treatment related to the neoplastic process.

• Patients with a platelet count above 30,000/mm3.

• Patients with no hemorrhagic symptomatology at the time of their inclusion

Exclusion Criteria:

• Patients with a history of clinically evident hemorrhagic episodes and/or with increased bleeding due to any other homeostatic alteration that contraindicates anticoagulant treatment and/or in the past two months have presented at least one of the following: active hemorrhaging or organic lesions susceptible to bleeding (e.g. active peptic ulcer, hemorrhagic cerebrovascular accident, aneurysms).

• Major surgery in the past two months.

• Known hypersensitivity to LMWH, heparin or substances of porcine origin.

• Patients with congenital or acquired bleeding diathesis.

• Damage to or surgical interventions of the central nervous system, eyes and ears within the past 6 months.

• Acute bacterial endocarditis or slow endocarditis.

• Patients with a history of heparin-associated thrombocytopenia.

• Patients with severe renal failure (serum creatinine over 2 mg/dl) or hepatic insufficiency (with values of AST and/or ALT > 5 times the normal value established by the reference range of the local hospital laboratory).

• Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).

• Patients with suspected inability/or inability to comply with treatment and/or complete the study.

• Patients who are participating in another clinical trial or have done so in the past 30 days.

• Patients with a life expectancy less than 3 months.

• Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.

• Patients on treatment with anticoagulants or who have been on treatment during the week previous to insert the CVC (including prophylaxis with heparin for hepatic veno-occlusive disease).

• Patients diagnosed with acute leukemia or awaiting a transplant from hematopoietic progenitors during the 90 days of the study.