CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)

NCT00219973 | Completed Phase 3 DMC

• 1 other identifier: ROV-BEM-2003-02
• Study Type: interventional
• Target: 526
• Locations: 4 countries
• Sites: 4

Brief Summary

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.

Conditions

Cancer; Venous Thromboembolism

Keywords

venous thromboembolism; deep vein thrombosis; pulmonary embolism; bleeding; low-molecular-weight heparin; cancer; surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

Interventions

Bemiparin DRUG

Bemiparin 3.500 IU/day for 28 days compared to 8 days

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rovi Pharmaceuticals Laboratories: lead

Study Sites (4)

Unknown Facility

Lisbon, Portugal

Location

Unknown Facility

Timișoara, Romania

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Madrid, Spain

Location

MeSH Terms

Conditions

Neoplasms; Venous Thromboembolism; Venous Thrombosis; Pulmonary Embolism; Hemorrhage

Interventions

bemiparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 19, 2005
• First Posted: September 22, 2005
• Study Start: May 1, 2005
• Study Completion: April 1, 2009
• Last Updated: April 28, 2010

Record last verified: 2010-04

Locations

RU (1); ES (1); RO (1); PT (1)