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:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
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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:
MedlinePlus related topics:
Blood Thinners
Drug Information available for:
Heparin
U.S. FDA Resources
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:
- Patients over 18 years who have given their informed consent to participate in the study.
- Patients receiving oral anticogulants during at least 3 months and who require outpatient surgery, laparoscopy surgery or invasive procedures
- Procedures must be performed from 8 am to 15 pm.
Exclusion Criteria:
- 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).
- Patients who have shown thromboembolic events with an appropriate INR.
- Known hypersensitivity to LMWH, heparin or substances of porcine origin.
- Patients with organic lesions susceptible to bleeding (e.g. active peptic ulcer, stroke, aneurysms).
- Patients with a history of heparin-induced thrombocytopenia.
- Patients with suspected inability/or inability to comply with treatment and/or complete the study.
- Patients who are participating in another clinical trial or have been participated in the past 30 days.
- Patients with antithrombin deficit and C and S protein deficit
- Women who are pregnant or breast-feeding, or with the possibility of becoming pregnant during the study.
- Acute bacterial endocarditis or slow endocarditis.
- Severe arterial hypertension (systolic blood pressure over 200 mmHg and/or diastolic blood pressure over 120 mmHg).
- Patients with antiplatelet therapy
- Patients with mechanical cardiac valves in mitral position and body weight 90 Kg with/or bone mass index (BMI) > 30 or 50 kg
- 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 May 21, 2013