Bemiparin Randomized Trial on Bridging Oral Anticoagulants in Invasive Procedures (BERTA Study) — BERTA  

Long-term Oral Anticoagulant Therapy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

THE MAIN OBJECTIVE of this study is to evaluate the efficacy and safety of the subcutaneous administration of Bemiparin 3,500 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Long-term Oral Anticoagulant Therapy

• NCT number: NCT00484822
• Study type: Interventional
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Status: Terminated
• Phase: Phase 3
• Start date: February 2007
• Completion date: May 2009