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Bemiparin

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

Vijay V Kakkar, Prof.

Paolo Prandoni, Prof.

Jose Luis Balibrea-Cantero, Prof.

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.

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.

CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)

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

Rovi Pharmaceuticals Laboratories

Placebo

Eduardo Rocha, MD

Ramon Lecumberri, MD

Vicente Vicente, MD

Pascual Marco, MD

José Mateo, MD

Albert Font, MD

Carmen Arratibel, MD

Francisco J. Capote, MD

Miguel Angel De gregorio Ariza, MD

Isabel Picón Roig, MD

Ricardo González Del Val Subirats, MD

Carlos Bosh Roig, MD

Pedro Pérez-Segura, MD

Vicente Alberola, MD

César Rodríguez Sánchez, MD

Ignacio Alberca Silva, MD

Javier García Frade, MD

Carmen Sedano, MD

Natividad Gómez, MD

Amalia Velasco, MD

Carmen Rodríguez Pinto, MD

Mihai Ciochinaru, MD

Cornelia Toganel, MD

Csaba Bela Szekely, MD

Mihaela Danciulescu, MD

Constantin Volovat, MD

Mircea Cazacu, Prof.

Eliade Ciuleanu, MD

Florin Bacanu, md

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 venous thrombosis (CVC-DVT)

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.

Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)

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)

Laboratorio farmacéutico ROVI

Clinica Universidad de Navarra, Universidad de Navarra

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)	NCT00219973	Cancer Venous Thromboe...	Bemiparin	40 Years -	Rovi Pharmaceuticals Laboratories
Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)	NCT00311896	Cancer Thrombosis	Bemiparin Placebo	18 Years -	Clinica Universidad de Navarra, Universidad de Navarra
Efficacy & Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter (BECAT)	NCT00311896	Cancer Thrombosis	Bemiparin Placebo	18 Years -	Clinica Universidad de Navarra, Universidad de Navarra

Spots Global Cancer Trial Database for bemiparin

Every month we try and update this database with for bemiparin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bemiparin

Every month we try and update this database with for bemiparin cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bemiparin cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.