CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)

This study has been completed.
Sponsor:
Information provided by:
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier:
NCT00219973
First received: September 19, 2005
Last updated: April 27, 2010
Last verified: April 2010
  Purpose

The aim of the study is to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, i.e. administering the first dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in oncological surgery.


Condition Intervention Phase
Cancer
Venous Thromboembolism
Drug: Bemiparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Multicentric, Rand., D-b, Pbo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of the Thromboprophylaxis With Bemiparin 3,500 IU/d for 28 Days Compared to 8 Days, in Patients Undergoing Oncological Abdominal/ Pelvic Surgery

Resource links provided by NLM:


Further study details as provided by Rovi Pharmaceuticals Laboratories:

Primary Outcome Measures:
  • EFFICACY: Combined incidence (from day 1 to day 20±2 after the randomisation): total DVT + non-fatal PE + all-cause mortality.
  • SAFETY: incidence of major bleeding (from day 1 to day 20±2 after the randomisation).

Secondary Outcome Measures:
  • EFFICACY: combined and isolated incidence of DVT (Total, proximal and distal), non-fatal PE, deaths related and not related with VTE.
  • SAFETY: incidence of major bleeding (from day 1 to day 82±8 after the randomisation) and incidence of minor bleeding (from day 1 to day 20±2 and to day 82±8 after the randomisation).
  • EXPLORATORY ANALYSES: Biological markers, tumour evolution and survival at 6 months.

Estimated Enrollment: 526
Study Start Date: May 2005
Study Completion Date: April 2009
Intervention Details:
    Drug: Bemiparin
    Bemiparin 3.500 IU/day for 28 days compared to 8 days
Detailed Description:

Although the efficacy of low-molecular-weight heparins(LMWH) in the prophylaxis of postoperative venous thromboembolism (VTE) is well established in a large number of studies, some aspects remain to be determined. The optimal duration of prophylactic treatment has not been clearly defined yet.

Traditionally, surgical prophylaxis of VTE in patients undergoing high-risk orthopaedic surgery was extended for one or two weeks after the operation. However, the most recent studies carried out on this field have demonstrated that prolongation of prophylaxis with LMWH for 4-6 weeks significantly reduces the incidence of VTE (by more than half) in patients undergoing orthopaedic surgery with a high-risk of VTE.

On the contrary, thromboprophylaxis in oncological surgery is generally limited to the period of hospitalisation, despite the fact that activation of coagulation is greater and more prolonged in patients undergoing surgery for neoplastic processes than in those patients not affected by cancer. The only two studies carried out to evaluate the efficacy of the prolongation of thromboprophylaxis for 4 weeks in this type of surgery seem to indicate that the VTE incidence could be reduced even further that with one-week prophylaxis, though these do not allow to establish a definitive conclusion.

The present study aims to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, giving the first dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in oncological surgery.

Additionally, some 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 (3,500 IU/day) on the survival of the patients at 6 months from the operation.

Four Study Committees have been created for this clinical trial in order to guarantee the safety of the patients as well as the highest quality data:

  • Trial Steering Committee
  • Data & Safety Monitoring Board
  • Committee for the Evaluation of Phlebographies
  • Committee for Adjudicating Clinical Events.
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients of 40 years of age or older, of either sex, who have given their informed consent to participate in the study.
  • 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 disease.
  • Patients undergoing surgery with general or spinal anaesthesia, with an estimated duration of surgery of over 30 minutes.
  • Patients with a life expectancy of at least 3 months.

Exclusion Criteria:

  • Curative or palliative surgery of a malignant neoplastic process in liver, biliary tract or pancreas.
  • Women who are pregnant or breast-feeding, or women with child-bearing potential who are not using effective contraceptive methods.
  • 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.
  • Patients with known hypersensitivity to the LMWHs, to heparin or to substances of porcine origin.
  • Patients with known hypersensitivity to radiological contrast media.
  • Patients with known hypersensitivity to anaesthetic drugs or pre-anaesthetic drugs.
  • Patients with a congenital or acquired bleeding diathesis (confirmed by hematological test), with or without haematuria.
  • 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.
  • Disseminated Intravascular Coagulation (DIC) attributable to heparin-induced thrombocytopenia.
  • Acute bacterial endocarditis and slow endocarditis.
  • Patients on treatment with oral or parenteral anticoagulants within 5 days before the operation.
  • Patients with a history of thrombocytopenia associated with heparin or with a current platelet count <75,000/mm3.
  • Patients with 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).
  • Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
  • 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.
  • Patients with suspected or confirmed inability to comply with the study treatment and/or follow-up.
  • Patients who are participating in another clinical trial or who have done so in the past 30 days.
  • Patients with a cava vein filter in place.
  • Patients needing the use of unallowed concomitant treatments or medications such as more than 125mg/day aspirin, NSAIDs with long half-life of significant anti-aggregation activity, metformin, or any anticoagulant compound (please refer to section of the protocol "Concomitant medications and treatments" for details)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219973

Locations
Portugal
Lisboa, Portugal
Romania
Timisoara, Romania
Russian Federation
Leningrad, Russian Federation
Spain
Madrid, Spain
Sponsors and Collaborators
Rovi Pharmaceuticals Laboratories
Investigators
Study Director: Vijay V Kakkar, Prof. Thrombosis Research Institute (London, UK)
Study Director: Paolo Prandoni, Prof. Faculty of Medicine, University of Padova (Padova, Italy)
Study Director: Jose Luis Balibrea-Cantero, Prof. Faculty of Medicine, Complutense University (Madrid, Spain)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00219973     History of Changes
Other Study ID Numbers: ROV-BEM-2003-02
Study First Received: September 19, 2005
Last Updated: April 27, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Rovi Pharmaceuticals Laboratories:
venous thromboembolism
deep vein thrombosis
pulmonary embolism
bleeding
low-molecular-weight heparin
cancer
surgery

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 29, 2014