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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001862-17 |
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The study has been halted prematurely due to a low recruitment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Brazo 1: Bemiparina Sódica 3.500 UI/día. |
|
| 2 | Placebo Comparator | Brazo 2: Heparina Cálcica 10.000 UI/día. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bemiparina Sodica | Drug | 3.500 UI/día. |
| |
| Heparina Cálcica |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fontcuberta Boj Jordi, Dr. | Fundació de Gestió Sanitaria del hospital de la Santa Creu i Sant Pau | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Alicante | Alicante | Alicante | 03010 | Spain | ||
| Hospital de Torrevieja |
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| Drug |
10.000 UI/día. |
|
| Torrevieja |
| Alicante |
| 03186 |
| Spain |
| Hospital Tries I Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Del Mar | Barcelona | Barcelona | 08003 | Spain |
| Fundació de Gestió Sanitaria de l'Hospital de la Santa Creu i sant Pau | Barcelona | Barcelona | 08025 | Spain |
| Hospital Sagrado Corazón | Barcelona | Barcelona | 08029 | Spain |
| Hospital de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Mataró | Mataró | Barcelona | 08304 | Spain |
| Hospital Mútua Terrassa | Terrassa | BARCELONA | 08221 | Spain |
| Hospital Consorci Sanitari de Terrassa | Terrassa | Barcelona | 08227 | Spain |
| Hospital Puerta Del Mar | Cadiz | Cadiz | 11009 | Spain |
| Hospital Provincial de Castellón | Castellon | Castellón | 12002 | Spain |
| Hospital General de Castellón | Castellon | Castellón | 12004 | Spain |
| Hospital de La Plana | Villarreal | Castellón | 12540 | Spain |
| Hospital Vinaroz | Vinaròs | Castellón | 12500 | Spain |
| Hospital de Jerez | Jerez de la Frontera | Cádiz | 11407 | Spain |
| Hospital Virgen de Las Nieves | Granada | Granada | 18012 | Spain |
| Hospital Arnau de Vilanova | Lleida | Lleida | 25198 | Spain |
| Hospital La Princesa | Madrid | Madrid | 28006 | Spain |
| Hospital Morales Messeguer | Murcia | Murcia | 30008 | Spain |
| HOSPITAL DE NAVARRA (Pamplona) | Pamplona | Navarre | 31008 | Spain |
| Hospital Comarcal de Valdeorras | O Barco de Valdeorras | Ourense | 32300 | Spain |
| Hospital Son Dureta | Palma de Mallorca | Palma de Mallorca | 07014 | Spain |
| Hospitalson Llàtzer | Palma de Mallorca | Palma de Mallorca | 07198 | Spain |
| Hospital Clínica Universitaria Pamplona | Pamplona | Pamplona | 31008 | Spain |
| Hospital Universitario de Salamanca | Salamanca | Salamanca | 37007 | Spain |
| Hospital Joan Xxiii | Tarragona | Tarragona | 43007 | Spain |
| HOSPITAL TORTOSA (Verge de la Cinta) | Tortosa | Tarragona | 43500 | Spain |
| Hospital de La Ribera | Alzira | Valencia | 46600 | Spain |
| HOSPITAL ARNAU DE VILANOVA(Valencia) | Valencia | Valencia | 46015 | Spain |
| Hospital Clinico Lozano Blesa | Zaragoza | Zaragoza | 50009 | Spain |