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

NCT ID: NCT00484822

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-05-31

Brief 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.

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.

Conditions

Long-term Oral Anticoagulant Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Brazo 1: Bemiparina Sódica 3.500 UI/día.

Group Type: EXPERIMENTAL

Bemiparina Sodica

Intervention Type: DRUG

3.500 UI/día.

2

Brazo 2: Heparina Cálcica 10.000 UI/día.

Group Type: PLACEBO_COMPARATOR

Heparina Cálcica

Intervention Type: DRUG

10.000 UI/día.

Interventions

Bemiparina Sodica

3.500 UI/día.

Intervention Type: DRUG

Heparina Cálcica

10.000 UI/día.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Institut de Recerca Hospital de la Santa Creu i Sant Pau

Principal Investigators

Fontcuberta Boj Jordi, Dr.

Role: STUDY_CHAIR

Fundació de Gestió Sanitaria del hospital de la Santa Creu i Sant Pau

Locations

Hospital General de Alicante

Alicante, Alicante, Spain

Hospital de Torrevieja

Torrevieja, Alicante, Spain

Hospital Tries I Pujol

Badalona, Barcelona, Spain

Hospital Del Mar

Barcelona, Barcelona, Spain

Fundació de Gestió Sanitaria de l'Hospital de la Santa Creu i sant Pau

Barcelona, Barcelona, Spain

Hospital Sagrado Corazón

Barcelona, Barcelona, Spain

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Mataró

Mataró, Barcelona, Spain

Hospital Mútua Terrassa

Terrassa, BARCELONA, Spain

Hospital Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Hospital Puerta Del Mar

Cadiz, Cadiz, Spain

Hospital Provincial de Castellón

Castellon, Castellón, Spain

Hospital General de Castellón

Castellon, Castellón, Spain

Hospital de La Plana

Villarreal, Castellón, Spain

Hospital Vinaroz

Vinaròs, Castellón, Spain

Hospital de Jerez

Jerez de la Frontera, Cádiz, Spain

Hospital Virgen de Las Nieves

Granada, Granada, Spain

Hospital Arnau de Vilanova

Lleida, Lleida, Spain

Hospital La Princesa

Madrid, Madrid, Spain

Hospital Morales Messeguer

Murcia, Murcia, Spain

HOSPITAL DE NAVARRA (Pamplona)

Pamplona, Navarre, Spain

Hospital Comarcal de Valdeorras

O Barco de Valdeorras, Ourense, Spain

Hospital Son Dureta

Palma de Mallorca, Palma de Mallorca, Spain

Hospitalson Llàtzer

Palma de Mallorca, Palma de Mallorca, Spain

Hospital Clínica Universitaria Pamplona

Pamplona, Pamplona, Spain

Hospital Universitario de Salamanca

Salamanca, Salamanca, Spain

Hospital Joan Xxiii

Tarragona, Tarragona, Spain

HOSPITAL TORTOSA (Verge de la Cinta)

Tortosa, Tarragona, Spain

Hospital de La Ribera

Alzira, Valencia, Spain

HOSPITAL ARNAU DE VILANOVA(Valencia)

Valencia, Valencia, Spain

Hospital Clinico Lozano Blesa

Zaragoza, Zaragoza, Spain

Countries

Spain

Other Identifiers

2006-001862-17

Identifier Type: -

Identifier Source: secondary_id

ACO-BEMI-01-2006

Identifier Type: -

Identifier Source: org_study_id