Status:
TERMINATED
Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborating Sponsors:
Laboratorio farmacéutico ROVI
Conditions:
Cancer
Thrombosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 v...
Detailed Description
Venous thromboembolism (VTE) is a common complication in patients with cancer principally in association with central vein catheters (CVC). The clinical benefit of antithrombotic prophylaxis for CVC-r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00311896
Start Date
July 1 2005
End Date
December 1 2010
Last Update
June 8 2012
Active Locations (19)
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1
Arad County Hospital
Arad, Romania
2
Cenral Emergency Clinical Military H.
Bucharest, Romania
3
Sf Maria Clinical Hospital
Bucharest, Romania
4
Oncology Institute Cuj-Napoca
Cluj-Napoca, Romania