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Sponsored by: |
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
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Information provided by: | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
ClinicalTrials.gov Identifier: | NCT00484822 |
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.
Condition | Intervention | Phase |
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Long-Term Oral Anticoagulant Therapy |
Drug: bemiparin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment |
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 |
Study Start Date: | February 2007 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Cuscullola Anna, Sra | 932158008 | acuscullola@infociencia.com |
Spain | |
Fundació de Gestió Sanitaria de l'Hospital de la Santa Creu i sant Pau | Recruiting |
Barcelona, Spain, 08025 | |
Contact: Santamaría Ortiz Amparo, Dra. | |
Principal Investigator: Santamaria Ortiz Amparo, Dra. |
Study Chair: | Fontcuberta Boj Jordi, Dr. | Fundació de Gestió Sanitaria del hospital de la Santa Creu i Sant Pau |
Study ID Numbers: | ACO-BEMI-01-2006, 2006-001862-17 |
Study First Received: | June 8, 2007 |
Last Updated: | June 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00484822 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Calcium, Dietary Anticoagulants Heparin, Low-Molecular-Weight Heparin Calcium heparin |
Anticoagulants Therapeutic Uses Hematologic Agents Pharmacologic Actions |