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

This study has been terminated.
(The study has been halted prematurely due to a low recruitment.)
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT00484822
First received: June 8, 2007
Last updated: February 3, 2010
Last verified: February 2010
  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: Bemiparina Sodica
Drug: Heparina Cálcica
Phase 3

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

Resource links provided by NLM:


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

Enrollment: 206
Study Start Date: February 2007
Estimated Study Completion Date: May 2009
Arms Assigned Interventions
Experimental: 1
Brazo 1: Bemiparina Sódica 3.500 UI/día.
Drug: Bemiparina Sodica
3.500 UI/día.
Placebo Comparator: 2
Brazo 2: Heparina Cálcica 10.000 UI/día.
Drug: Heparina Cálcica
10.000 UI/día.

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 and older
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

Locations
Spain
Hospital de Torrevieja
Torrevieja, Alicante, Spain, 03186
Hospital Tries I Pujol
Badalona, Barcelona, Spain, 08916
Hospital de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Mataró
Mataró, Barcelona, Spain, 08304
Hospital Mútua Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Hospital de La Plana
Villarreal, Castellón, Spain, 12540
Hospital Vinaroz
Vinaroz, Castellón, Spain, 12500
Hospital de Jerez
Jerez de La Frontera, Cádiz, Spain, 11407
HOSPITAL DE NAVARRA (Pamplona)
Pamplona, Navarra, Spain, 31008
Hospital Comarcal de Valdeorras
O Barco de Valdeorras, Ourense, Spain, 32300
HOSPITAL TORTOSA (Verge de la Cinta)
Tortosa, Tarragona, Spain, 43500
Hospital de La Ribera
Alzira, Valencia, Spain, 46600
Hospital General de Alicante
Alicante, Spain, 03010
Hospital Del Mar
Barcelona, Spain, 08003
Fundació de Gestió Sanitaria de l'Hospital de la Santa Creu i sant Pau
Barcelona, Spain, 08025
Hospital Sagrado Corazón
Barcelona, Spain, 08029
Hospital Puerta Del Mar
Cadiz, Spain, 11009
Hospital Provincial de Castellón
Castellón, Spain, 12002
Hospital General de Castellón
Castellón, Spain, 12004
Hospital Virgen de Las Nieves
Granada, Spain, 18012
Hospital Arnau de Vilanova
Lleida, Spain, 25198
Hospital La Princesa
Madrid, Spain, 28006
Hospital Morales Messeguer
Murcia, Spain, 30008
Hospital Son Dureta
Palma de Mallorca, Spain, 07014
Hospitalson Llàtzer
Palma de Mallorca, Spain, 07198
Hospital Clínica Universitaria Pamplona
Pamplona, Spain, 31008
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Hospital Joan Xxiii
Tarragona, Spain, 43007
HOSPITAL ARNAU DE VILANOVA(Valencia)
Valencia, Spain, 46015
Hospital Clinico Lozano Blesa
Zaragoza, Spain, 50009
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

Responsible Party: Institut de Recerca Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT00484822     History of Changes
Other Study ID Numbers: ACO-BEMI-01-2006, 2006-001862-17
Study First Received: June 8, 2007
Last Updated: February 3, 2010
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Anticoagulants
Heparin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 22, 2014