Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219973
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2005-09-19
Brief Title:
CANBESURE STUDY Cancer Bemiparin and Surgery Evaluation
Sponsor:
Rovi Pharmaceuticals Laboratories
Organization:
Rovi Pharmaceuticals Laboratories
Study Overview
Official Title:
Multicentric Rand D-b Pbo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of the Thromboprophylaxis With Bemiparin 3500 IUd for 28 Days Compared to 8 Days in Patients Undergoing Oncological Abdominal Pelvic Surgery
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 heparinsLMWH 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 3500 IUday 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 3500 IUday 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 3500 IUday 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
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 3500 IUday 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 3500 IUday 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 3500 IUday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None