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

Long-term Oral Anticoagulant Therapy Clinical Trial

— BERTA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00484822
• Other study ID #: ACO-BEMI-01-2006
• Secondary ID: 2006-001862-17
• Status: Terminated
• Phase: Phase 3
• First received: June 8, 2007
• Last updated: February 3, 2010
• Start date: February 2007
• Est. completion date: May 2009

Study information

• Verified date: February 2010
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 206
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Long-term Oral Anticoagulant Therapy

Intervention

Drug:
• Bemiparina Sodica
3.500 UI/día.
• Heparina Cálcica
10.000 UI/día.

Locations

Country	Name	City	State
Spain	Hospital General de Alicante	Alicante
Spain	Hospital de La Ribera	Alzira	Valencia
Spain	Hospital Tries I Pujol	Badalona	Barcelona
Spain	Fundació de Gestió Sanitaria de l'Hospital de la Santa Creu i sant Pau	Barcelona
Spain	Hospital Del Mar	Barcelona
Spain	Hospital Sagrado Corazón	Barcelona
Spain	Hospital Puerta Del Mar	Cadiz
Spain	Hospital General de Castellón	Castellón
Spain	Hospital Provincial de Castellón	Castellón
Spain	Hospital Virgen de Las Nieves	Granada
Spain	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital de Jerez	Jerez de La Frontera	Cádiz
Spain	Hospital Arnau de Vilanova	Lleida
Spain	Hospital La Princesa	Madrid
Spain	Hospital Mataró	Mataró	Barcelona
Spain	Hospital Morales Messeguer	Murcia
Spain	Hospital Comarcal de Valdeorras	O Barco de Valdeorras	Ourense
Spain	Hospital Son Dureta	Palma de Mallorca
Spain	Hospitalson Llàtzer	Palma de Mallorca
Spain	Hospital Clínica Universitaria Pamplona	Pamplona
Spain	HOSPITAL DE NAVARRA (Pamplona)	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Joan Xxiii	Tarragona
Spain	Hospital Consorci Sanitari de Terrassa	Terrassa	Barcelona
Spain	Hospital Mútua Terrassa	Terrassa	Barcelona
Spain	Hospital de Torrevieja	Torrevieja	Alicante
Spain	HOSPITAL TORTOSA (Verge de la Cinta)	Tortosa	Tarragona
Spain	HOSPITAL ARNAU DE VILANOVA(Valencia)	Valencia
Spain	Hospital de La Plana	Villarreal	Castellón
Spain	Hospital Vinaroz	Vinaroz	Castellón
Spain	Hospital Clinico Lozano Blesa	Zaragoza

Sponsors (1)

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

Country where clinical trial is conducted

Spain,