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

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

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.

Study Overview

• Status: Terminated
• Conditions: Long-term Oral Anticoagulant Therapy
• Intervention / Treatment: Drug: Bemiparina Sodica; Drug: Heparina Cálcica

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.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Study Completion (ANTICIPATED): May 1, 2009

Study Registration Dates

• First Submitted: June 8, 2007
• First Submitted That Met QC Criteria: June 8, 2007
• First Posted (ESTIMATE): June 11, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): February 4, 2010
• Last Update Submitted That Met QC Criteria: February 3, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: ACO-BEMI-01-2006; 2006-001862-17