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Bemiparin Randomized Trial on Bridging Oral Anticoagulants in Invasive Procedures (BERTA Study)
This study is currently recruiting participants.
Verified by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, June 2007
First Received: June 8, 2007   No Changes Posted
Sponsored by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT00484822
  Purpose

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
Long-Term Oral Anticoagulant Therapy
Drug: bemiparin
Phase III

MedlinePlus related topics: Blood Thinners Surgery
U.S. FDA Resources
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

Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Study Start Date: February 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients over 18 years who have given their informed consent to participate in the study.
  2. Patients receiving oral anticogulants during at least 3 months and who require outpatient surgery, laparoscopy surgery or invasive procedures
  3. Procedures must be performed from 8 am to 15 pm.

Exclusion Criteria:

  1. Patients with severe renal failure (creatinine clearance <30 ml/min) or hepatic insufficiency (AST and/or ALT>5 times the normal value established by the reference range of the local hospital laboratory).
  2. Patients who have shown thromboembolic events with an appropriate INR.
  3. Known hypersensitivity to LMWH, heparin or substances of porcine origin.
  4. Patients with organic lesions susceptible to bleeding (e.g. active peptic ulcer, stroke, aneurysms).
  5. Patients with a history of heparin-induced thrombocytopenia.
  6. Patients with suspected inability/or inability to comply with treatment and/or complete the study.
  7. Patients who are participating in another clinical trial or have been participated in the past 30 days.
  8. Patients with antithrombin deficit and C and S protein deficit
  9. Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
  10. Acute bacterial endocarditis or slow endocarditis.
  11. Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
  12. Patients with antiplatelet therapy
  13. Patients with mechanical cardiac valves in mitral position and body weight  90 Kg with/or bone mass index (BMI) > 30 or  50 kg
  14. Patients with Starr-Edwards valves.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484822

Contacts
Contact: Cuscullola Anna, Sra 932158008 acuscullola@infociencia.com

Locations
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.            
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Study Chair: Fontcuberta Boj Jordi, Dr. Fundació de Gestió Sanitaria del hospital de la Santa Creu i Sant Pau
  More Information

No publications provided

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

Study placed in the following topic categories:
Calcium, Dietary
Anticoagulants
Heparin, Low-Molecular-Weight
Heparin
Calcium heparin

Additional relevant MeSH terms:
Anticoagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009