drugset / Trial / NCT00484822

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

NCT00484822

Phase 3 Terminated 206 enrolled Sant Pau Research Institute
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2007-02
Primary completion
Completion
2009-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bemiparin Other / unclassified 3500 iu Subcutaneous
Comparator Heparina Unknown 10000 iu

Indications

No indication recorded.