Clinical trial NCT00484822: Bemiparin Randomized Trial on Bridging Oral Anticoagulants in Invasive Procedures (BERTA Study)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Long-term Oral Anticoagulant Therapy
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2007-06-11
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Torrevieja
country: Spain
facility: Hospital de Torrevieja
state: Alicante
city: Badalona
country: Spain
facility: Hospital Tries I Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Mataró
country: Spain
facility: Hospital Mataró
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mútua Terrassa
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Consorci Sanitari de Terrassa
state: Barcelona
city: Villarreal
country: Spain
facility: Hospital de La Plana
state: Castellón
city: Vinaroz
country: Spain
facility: Hospital Vinaroz
state: Castellón
city: Jerez de La Frontera
country: Spain
facility: Hospital de Jerez
state: Cádiz
city: Pamplona
country: Spain
facility: HOSPITAL DE NAVARRA (Pamplona)
state: Navarra
city: O Barco de Valdeorras
country: Spain
facility: Hospital Comarcal de Valdeorras
state: Ourense
city: Tortosa
country: Spain
facility: HOSPITAL TORTOSA (Verge de la Cinta)
state: Tarragona
city: Alzira
country: Spain
facility: Hospital de La Ribera
state: Valencia
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Barcelona
country: Spain
facility: Hospital Del Mar
city: Barcelona
country: Spain
facility: Fundació de Gestió Sanitaria de l'Hospital de la Santa Creu i sant Pau
city: Barcelona
country: Spain
facility: Hospital Sagrado Corazón
city: Cadiz
country: Spain
facility: Hospital Puerta Del Mar
city: Castellón
country: Spain
facility: Hospital Provincial de Castellón
city: Castellón
country: Spain
facility: Hospital General de Castellón
city: Granada
country: Spain
facility: Hospital Virgen de Las Nieves
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Murcia
country: Spain
facility: Hospital Morales Messeguer
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: Palma de Mallorca
country: Spain
facility: Hospitalson Llàtzer
city: Pamplona
country: Spain
facility: Hospital Clínica Universitaria Pamplona
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Tarragona
country: Spain
facility: Hospital Joan Xxiii
city: Valencia
country: Spain
facility: HOSPITAL ARNAU DE VILANOVA(Valencia)
city: Zaragoza
country: Spain
facility: Hospital Clinico Lozano Blesa
Study officials:
affiliation: Fundació de Gestió Sanitaria del hospital de la Santa Creu i Sant Pau
name: Fontcuberta Boj Jordi, Dr.
role: STUDY_CHAIR
References: