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Multicentric, Randomized, Placebo Controlled and Double-blind Study to Evaluate the Efficacy and Safety of Antithrombotic Prophylaxis With Bemiparin (3,500 UI/Day) in Cancer Patients With a Central Venous Catheter (CVC)(BECAT)


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer, Thrombosis

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Trial Information

Multicentric, Randomized, Placebo Controlled and Double-blind Study to Evaluate the Efficacy and Safety of Antithrombotic Prophylaxis With Bemiparin (3,500 UI/Day) in Cancer Patients With a Central Venous Catheter (CVC)(BECAT)


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-related VTE in cancer patients remains unclear.The aim of this study is
to evaluate the efficacy and safety of the administration of Bemiparin in cancer patients
with a central venous catheter (CVC). This study is designed as a multicenter, randomized,
double-blind, placebo-controlled study. On the day of CVC insertion, eligible patients are
randomly assigned to receive subcutaneously either bemiparin (3,500 UI/day) or placebo by
using preloaded syringes for 45 days.

The primary efficacy endpoint will be the combined incidence during the double blind
treatment period of Clinical or symptomatic CVC-DVT verified objectively (Doppler
ultrasonography or phlebography)and subclinical or asymptomatic CVC-DVT confirmed by
elective bilateral Doppler ultrasonography performed 45±5 days after randomization.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

Clinical or symptomatic CVC-DVT verified objectively (Doppler ultrasonography or phlebography).

Principal Investigator

Eduardo Rocha, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Clinica Universitaria de Navarra

Authority:

Spain: Spanish Agency of Medicines

Study ID:

ICT-BEM-2004-02

NCT ID:

NCT00311896

Start Date:

July 2005

Completion Date:

December 2010

Related Keywords:

  • Cancer
  • Thrombosis
  • Cancer
  • Thrombosis
  • Catheter
  • Bemiparin
  • Prophylaxis
  • Thrombosis

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