Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484822
Status:
TERMINATED
Last Update Posted:
2010-02-04
First Post:
2007-06-08
Brief Title:
Bemiparin Randomized Trial on Bridging Oral Anticoagulants in Invasive Procedures BERTA Study
Sponsor:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Organization:
Fundació Institut de Recerca de lHospital de la Santa Creu i Sant Pau
Study Overview
Official Title:
Multicentric Randomized Controlled Double-blind Clinical Trial to Assess Perioperative Bridging Therapy With Sodium Bemiparin vs Calcium Unfractionated Heparin in Invasive Procedures Outpatient Surgery and Laparoscopy Surgery in Patients Receiving Long-term Oral Anticoagulant Therapy
Status:
TERMINATED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study has been halted prematurely due to a low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BERTA
Brief Summary:
Often it is necessary to temporarily discontinue OAT when surgical or other invasive procedures are required However there is no consensus on the optimal management in these situations and heparin bridging therapy is the current usual practice in these situations No large randomized controlled clinical trials have been yet performed to evaluate the efficacy and safety of a low molecular weight heparins LMWH as bridging therapy
Detailed Description:
THE MAIN OBJECTIVE of this study is to evaluate the efficacy and safety of the subcutaneous administration of Bemiparin 3500 IU for the peri-operative procedural management of patients requiring temporary interruption of oral anticoagulation therapy OAT
PRIMARY EFFICACY ENDPOINT combined incidence of arterial and venous thromboembolic events and deaths from any causes within 3 months after the invasive procedure
PRIMARY SAFETY ENDPOINT incidence of major bleeding within 10 days after the invasive procedure
PRIMARY EFFICACY ENDPOINT combined incidence of arterial and venous thromboembolic events and deaths from any causes within 3 months after the invasive procedure
PRIMARY SAFETY ENDPOINT incidence of major bleeding within 10 days after the invasive procedure
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 |
|---|---|---|---|
| 2006-001862-17 | None | None | None |