Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311896
Status:
TERMINATED
Last Update Posted:
2012-06-08
First Post:
2006-04-05
Brief Title:
Efficacy Safety of Prophylaxis With Bemiparin in Cancer Patients With a Central Venous Catheter BECAT
Sponsor:
Clinica Universidad de Navarra Universidad de Navarra
Organization:
Clinica Universidad de Navarra Universidad de Navarra
Study Overview
Official Title:
Multicentric Randomized Placebo Controlled and Double-blind Study to Evaluate the Efficacy and Safety of Antithrombotic Prophylaxis With Bemiparin 3500 UIDay in Cancer Patients With a Central Venous Catheter CVCBECAT
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor stopped due to difficulties to recruit 402 patients required by protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of the subcutaneous administration for 45 days of Bemiparin 3500 UIday in cancer patients with a CVC to prevent CVC-related deep venous thrombosis CVC-DVT
Detailed Description:
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 unclearThe 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 3500 UIday 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 phlebographyand subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 455 days after randomization
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 phlebographyand subclinical or asymptomatic CVC-DVT confirmed by elective bilateral Doppler ultrasonography performed 455 days after randomization
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BECAT | None | None | None |