search
Back to results

CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)

Primary Purpose

Cancer, Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bemiparin
Sponsored by
Rovi Pharmaceuticals Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer focused on measuring venous thromboembolism, deep vein thrombosis, pulmonary embolism, bleeding, low-molecular-weight heparin, cancer, surgery

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Outcomes

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.

Full Information

First Posted
September 19, 2005
Last Updated
April 27, 2010
Sponsor
Rovi Pharmaceuticals Laboratories
search

1. Study Identification

Unique Protocol Identification Number
NCT00219973
Brief Title
CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rovi Pharmaceuticals Laboratories

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Venous Thromboembolism
Keywords
venous thromboembolism, deep vein thrombosis, pulmonary embolism, bleeding, low-molecular-weight heparin, cancer, surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
526 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bemiparin
Intervention Description
Bemiparin 3.500 IU/day for 28 days compared to 8 days
Primary Outcome Measure Information:
Title
EFFICACY: Combined incidence (from day 1 to day 20±2 after the randomisation): total DVT + non-fatal PE + all-cause mortality.
Title
SAFETY: incidence of major bleeding (from day 1 to day 20±2 after the randomisation).
Secondary Outcome Measure Information:
Title
EFFICACY: combined and isolated incidence of DVT (Total, proximal and distal), non-fatal PE, deaths related and not related with VTE.
Title
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).
Title
EXPLORATORY ANALYSES: Biological markers, tumour evolution and survival at 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vijay V Kakkar, Prof.
Organizational Affiliation
Thrombosis Research Institute (London, UK)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paolo Prandoni, Prof.
Organizational Affiliation
Faculty of Medicine, University of Padova (Padova, Italy)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jose Luis Balibrea-Cantero, Prof.
Organizational Affiliation
Faculty of Medicine, Complutense University (Madrid, Spain)
Official's Role
Study Director
Facility Information:
City
Lisboa
Country
Portugal
City
Timisoara
Country
Romania
City
Leningrad
Country
Russian Federation
City
Madrid
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)

We'll reach out to this number within 24 hrs