Bemiparin Randomized Trial on Bridging Oral Anticoagulants in Invasive Procedures (BERTA Study)
NCT00484822 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206
Last updated 2010-02-04
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.
Conditions
- Long-term Oral Anticoagulant Therapy
Interventions
- DRUG
-
Bemiparina Sodica
3.500 UI/día.
- DRUG
-
Heparina Cálcica
10.000 UI/día.
Sponsors & Collaborators
-
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
lead OTHER
Principal Investigators
-
Fontcuberta Boj Jordi, Dr. · Fundació de Gestió Sanitaria del hospital de la Santa Creu i Sant Pau
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-02-28
- Completion
- 2009-05-31
Countries
- Spain
Study Locations
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