Computerized Registry of Patients With Venous Thromboembolism (RIETE)
Sponsor
Manuel Monreal (Other)
Overall Status
Recruiting
CT.gov ID
NCT02832245
Collaborator
(none)
120,000
215
321
558.1
1.7
Study Details
Study Description
Brief Summary
The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a multidisciplinary Project initiated in march 2001 and consisting in obtaining an extensive data registry of consecutive patients with venous thromboembolism.
The main objective is to provide information on the Internet to help physicians to improve their knowledge on the natural history of thromboembolic disease, particularly in those subgroups of patients who are usually not recruited in randomized clinical trials (pregnant women, elderly patients, disseminated cancer, severe renal insufficiency, patients with contraindications to anticoagulation therapy, extreme body weight, etc), with the purpose of decreasing mortality, frequency of thromboembolic recurrences as well as bleeding complications and arterial events.
As an additional objective RIETE is also aimed to create predictive scores that help physicians to better identify patients with high risk of presenting some of these complications.
The primary parameters recorded by the registry comprise details of each patient's clinical status, including any coexisting or underlying conditions, and the type, dose, duration and outcome (during the first 3 months of therapy) of antithrombotic treatment. Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Detailed Description
The RIETE Registry pretends the improvement of care of patients with thromboembolic disease. Very often the investigators pose serious doubts on how to manage a specific patient. Sometimes because it is a patient with thrombocytopenia, a pregnant woman, a patient with a recent cerebral bleeding or cerebral metastasis, a patient with gastroduodenal ulcer or hepatic cirrhosis. There is no clinical evidence about how the investigators should manage these patients and the investigators have to individualize its management. The bibliography available is not of much help. Only if the investigators have a database with a sufficient number of cases, they may be able to make evidence based decisions.
This database on the Internet will allow the investigators to consult and obtain an immediate response when taking care of a patient who needs an individualized management. After introducing the patient the investigators will automatically obtain the data of all patients with similar clinical profiles. And this will help the investigators to identify high-risk patients and thus facilitate them preventing possible future complications.
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
120000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Computerized Registry of Patients With Venous Thromboembolism (RIETE)
Study Start Date
:
Mar 1, 2001
Anticipated Primary Completion Date
:
Dec 1, 2026
Anticipated Study Completion Date
:
Dec 1, 2027
Outcome Measures
Primary Outcome Measures
- VTE events and complications [3 years]
Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Confirmed VTE (acute deep-vein thrombosis, pulmonary embolism and/or superficial venous thrombosis) by objective tests.
-
Informed consent to the participation in the study, according to the requirements of the ethics committee within each hospital.
Exclusion Criteria:
-
Participation in a therapeutic clinical trial with an unknown drug.
-
Inability to the 3 month follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale University School of Medicine | New Haven | Connecticut | United States | 06510 |
| 2 | Evanston NorthShore University HealthSystem | Evanston | Illinois | United States | 60201 |
| 3 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 4 | Northwell Health System | Manhasset | New York | United States | 11021 |
| 5 | Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 6 | Clínica Privada Pueyrredón | Mar Del Plata | Buenos Aires | Argentina | |
| 7 | Clínica San Camilo | Buenos Aires | Argentina | ||
| 8 | Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | ||
| 9 | Medical University of Vienna | Vienna | Austria | ||
| 10 | Hospital UZ Leuven | Leuven | Belgium | ||
| 11 | Hospital Jorge Valente | Salvador De Bahía | Bahía | Brazil | |
| 12 | Botucatu Medical School - São Paulo State University (UNESP) | Botucatu | São Paulo | Brazil | |
| 13 | Peking University Cancer Hospital and Institute | Beijing | Beijing | China | |
| 14 | Hospital Universitario Fundación Santa Fé de Bogota | Bogotá | Colombia | ||
| 15 | University Hospital Hradec Kralove | Hradec Králové | Czechia | ||
| 16 | University Hospital Plzen | Plzen | Czechia | ||
| 17 | Hospital Luis Vernaza | Guayaquil | Guayas | Ecuador | |
| 18 | Hospital Clínica La Merced | Quito | Ecuador | ||
| 19 | Hospital SOLCA Núcleo de Quito | Quito | Ecuador | ||
| 20 | Ain Shams University Specialized Hospital | Cairo | Egypt | ||
| 21 | Médipôle Hôpital Mutualiste | Villeurbanne | Lyon | France | |
| 22 | Hospital Center of Avignon | Avignon | Provenza | France | |
| 23 | Institut Sainte Catherine | Avignon | Provenza | France | |
| 24 | Hôpital Nord - CHU St-Etienne | Saint-Étienne | Saint-Etienne | France | |
| 25 | University Hospital Jean Minjoz | Besançon | France | ||
| 26 | CHRU Brest | Brest | France | ||
| 27 | Clermont-Ferrand University Hospital | Clermont-Ferrand | France | ||
| 28 | Hôpital Louis Mourier | Colombes | France | ||
| 29 | CHU de Dijon Bourgogne | Dijon | France | ||
| 30 | Hôpital Édouard Herriot | Lyon | France | ||
| 31 | Hôpital de la Timone | Marseille | France | ||
| 32 | Hôpital Saint Eloi | Montpellier | France | ||
| 33 | CHU Nantes | Nantes | France | ||
| 34 | Hôpital Europeen Georges Pompidou | Paris | France | ||
| 35 | Hôpital Lariboisiere | Paris | France | ||
| 36 | Hôpital Paris Saint-Joseph | Paris | France | ||
| 37 | Hôpital Saint-Louis | Paris | France | ||
| 38 | Centre Hospitalier Lyon Sud | Pierre-Bénite | France | ||
| 39 | Hôpital de Rangueil | Toulouse | France | ||
| 40 | Municipal Hospital of Dresden Friedrichstadt | Dresden | Germany | ||
| 41 | Hospital Papageorgiou | Salónica | Saloniki | Greece | |
| 42 | Hospital Escuela Universitario | Tegucigalpa | Honduras | ||
| 43 | Imam Reza Hospital | Tabriz | Azerbaiyán Oriental | Iran, Islamic Republic of | |
| 44 | Abu-Ali- Sina Organ Transplant Center (OCT) | Shiraz | Fars | Iran, Islamic Republic of | |
| 45 | Masih-Daneshvari Hospital | Tehran | Iran, Islamic Republic of | ||
| 46 | Rajaie Cardiovascular Medical and Research Center | Tehran | Iran, Islamic Republic of | ||
| 47 | Tehran Heart Center | Tehran | Iran, Islamic Republic of | ||
| 48 | Mater Misericordiae University Hospital | Dublin | Leinster | Ireland | |
| 49 | Sheba Medical Center | Ramat Gan | Tel Hashomer | Israel | |
| 50 | Rambam Healthcare Campus | Haifa | Israel | ||
| 51 | Galilee Medical Center | Nahariya | Israel | ||
| 52 | Hematology Institute of ZIV Medical Center | Safed | Israel | ||
| 53 | AORN San Giuseppe Moscati Avellino | Avellino | Campania | Italy | |
| 54 | Ospedale Buon Consiglio Fatebenefratelli | Naples | Campania | Italy | |
| 55 | Hospital of Marcianise | Marcianise | Caserta | Italy | |
| 56 | Ospedale CastelFranco Veneto | Castelfranco | Castelfranco Veneto | Italy | |
| 57 | Casa Sollievo Della Sofferenza | San Giovanni Rotondo | Foggia | Italy | |
| 58 | Ospedale Galliera | Genoa | Genova | Italy | |
| 59 | Ospedale SS. Filippo e Nicola | Avezzano | L'Aquila | Italy | |
| 60 | Istituto Clinico Humanitas IRCCS | Rozzano | Milan | Italy | |
| 61 | University of Padua | Padua | Veneto | Italy | |
| 62 | Istituti Ospitalieri di Cremona | Cremona | Italy | ||
| 63 | A.O.U Policlinico "G. Martino" | Messina | Italy | ||
| 64 | Federico II University Hospital | Naples | Italy | ||
| 65 | Azienda Ospedaliera Universitaria di Parma | Parma | Italy | ||
| 66 | Azienda U.S.L. Di Ravenna - O.C. Di Faenza | Ravenna | Italy | ||
| 67 | Hospital Rieti | Rieti | Italy | ||
| 68 | Ospedale Infermi | Rimini | Italy | ||
| 69 | "A. Gemelli " Hospital | Rome | Italy | ||
| 70 | Ospedale San Camillo | Rome | Italy | ||
| 71 | Ospedale St. John | Rome | Italy | ||
| 72 | Ospedale Santa Maria della Misericordia | Udine | Italy | ||
| 73 | Università dell´Insubria | Varese | Italy | ||
| 74 | Ospedale SS. Giovanni e Paolo di Venezia | Venice | Italy | ||
| 75 | Kokura Memorial Hospital | Kitakyushu | Fukuoka | Japan | |
| 76 | Gunma University Hospital | Maebashi | Gunma | Japan | |
| 77 | Hyogo Prefectural Amagasaki General Medical Center | Amagasaki | Hyogo | Japan | |
| 78 | Mie University Hospital | Tsu | Mie | Japan | |
| 79 | Kumamoto University Hospital | Kumamoto | Japan | ||
| 80 | Kyoto University Hospital | Kyoto | Japan | ||
| 81 | Nagasaki University Hospital | Nagasaki | Japan | ||
| 82 | Osaka Saiseikai Noe Hospital | Osaka | Japan | ||
| 83 | Japanese Red Cross Wakayama Medical Center | Wakayama | Japan | ||
| 84 | Pauls Stradins Clinical University Hospital | Riga | Latvia | ||
| 85 | Ibn Sina Hospital | Rabat | Morocco | ||
| 86 | PHI University Clinic of Pulmology and Allergy Skopje | Skopje | North Macedonia | ||
| 87 | University Cardiology Clinic | Skopje | North Macedonia | ||
| 88 | Centro Hospitalar do Médio Ave | Vila Nova De Famalicão | Famalicão | Portugal | |
| 89 | Hospital Pedro Hispano - Unidade Local de Saúde de Matosinhos | Senhora Da Hora | Matosinhos | Portugal | |
| 90 | Centro Hospitalar de Entre o Douro e Vouga | Santa Maria Da Feira | Santa María Da Feira | Portugal | |
| 91 | Hospital García de Orta | Almada | Setúbal | Portugal | |
| 92 | Hospital General de Santo Antonio Porto | Porto | Portugal | ||
| 93 | Centro Hospitalar Gaia/Espinho, EPE | Vila Nova De Gaia | Portugal | ||
| 94 | Complejo Hospitalario Universitario de Ferrol | Ferrol | A Coruña | Spain | |
| 95 | Hospital Comarcal de Barbanza | Ribeira | A Coruña | Spain | |
| 96 | Hospital Clínico Universitario de Santiago | Santiago De Compostela | A Coruña | Spain | |
| 97 | Hospital General Universitario de Elche | Elche | Alicante | Spain | |
| 98 | Hospital Universitario de Vinalopó | Elche | Alicante | Spain | |
| 99 | Hospital General Universitario de Elda | Elda | Alicante | Spain | |
| 100 | Hospital Vega Baja | Orihuela | Alicante | Spain | |
| 101 | Hospital de Poniente | El Ejido | Almería | Spain | |
| 102 | Hospital Valle del Nalón | Langreo | Asturias | Spain | |
| 103 | Hospital Municipal de Badalona | Badalona | Barcelona | Spain | |
| 104 | Hospital Universitario Germans Trias i Pujol | Badalona | Barcelona | Spain | |
| 105 | Hospital General de Granollers | Granollers | Barcelona | Spain | |
| 106 | Hospital Universitario de Bellvitge | Hospitalet de Llobregat | Barcelona | Spain | |
| 107 | Althaia, Xarxa Assistencial Universitària de Manresa | Manresa | Barcelona | Spain | |
| 108 | Consorci Hospitalari de Mataró | Mataró | Barcelona | Spain | |
| 109 | Corporación Sanitaria Parc Taulí | Sabadell | Barcelona | Spain | |
| 110 | Parc Sanitari Sant Joan de Deu | Sant Boi De Llobregat | Barcelona | Spain | |
| 111 | Hospital Universitario General de Cataluña | Sant Cugat Del Vallès | Barcelona | Spain | |
| 112 | Hospital Sant Joan Despí-Moisés Broggi | Sant Joan Despí | Barcelona | Spain | |
| 113 | Hospital Sant Camil | Sant Pere De Ribes | Barcelona | Spain | |
| 114 | Fundació Hospital del L'Esperit Sant | Santa Coloma De Gramenet | Barcelona | Spain | |
| 115 | Hospital Universitario Mutua Terrassa | Terrassa | Barcelona | Spain | |
| 116 | Hospital Comarcal de L'Alt Penedés | Vilafranca Del Penedès | Barcelona | Spain | |
| 117 | Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | Spain | |
| 118 | Hospital Sierrallana | Torrelavega | Cantabria | Spain | |
| 119 | Consorcio Hospitalario Provincial de Castellón | Castellón De La Plana | Castellón | Spain | |
| 120 | Hospital General Universitari de Castelló | Castellón De La Plana | Castellón | Spain | |
| 121 | Hospital Santa Bárbara | Puertollano | Ciudad Real | Spain | |
| 122 | Hospital Jerez de la Frontera | Jerez De La Frontera | Cádiz | Spain | |
| 123 | Hospital Universitario Puerto Real | Puerto Real | Cádiz | Spain | |
| 124 | Hospital Infanta Margarita | Cabra | Córdoba | Spain | |
| 125 | Hospital de Montilla | Montilla | Córdoba | Spain | |
| 126 | Hospital de Figueres | Figueres | Gerona | Spain | |
| 127 | Hospital d'Olot i Comarcal de la Garrotxa | Olot | Gerona | Spain | |
| 128 | Hospital de Palamós | Palamós | Gerona | Spain | |
| 129 | Hospital del Alto Guadalquivir Andújar | Jaén | Jaen | Spain | |
| 130 | Hospital San Pedro | Logroño | La Rioja | Spain | |
| 131 | Hospital Doctor José Molina Orosa | Arrecife | Lanzarote | Spain | |
| 132 | Complejo Hospitalario Insular-Materno Infantil | Las Palmas De Gran Canaria | Las Palmas | Spain | |
| 133 | Hospital Universitario de Gran Canaria Dr. Negrín | Las Palmas De Gran Canaria | Las Palmas | Spain | |
| 134 | Fundación Hospital Alcorcón | Alcorcón | Madrid | Spain | |
| 135 | Hospital del Tajo | Aranjuez | Madrid | Spain | |
| 136 | Hospital Universitario HM Monteprincipe | Boadilla del Monte | Madrid | Spain | |
| 137 | Hospital Monográfico ASEPEYO | Coslada | Madrid | Spain | |
| 138 | Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid | Spain | |
| 139 | Hospital Universitario de Móstoles | Móstoles | Madrid | Spain | |
| 140 | Hospital Universitario Rey Juan Carlos | Móstoles | Madrid | Spain | |
| 141 | Hospital Universitario Infanta Sofía | San Sebastián De Los Reyes | Madrid | Spain | |
| 142 | Hospital Comarcal de la Axarquía | Vélez-Málaga | Malaga | Spain | |
| 143 | Hospital General Universitario Santa Lucía | Cartagena | Murcia | Spain | |
| 144 | Hospital Rafael Méndez de Lorca | Lorca | Murcia | Spain | |
| 145 | Hospital Virgen del Castillo | Yecla | Murcia | Spain | |
| 146 | Clínica Universitaria de Navarra | Pamplona | Navarra | Spain | |
| 147 | Complejo Hospitalario de Navarra | Pamplona | Navarra | Spain | |
| 148 | Hospital Reina Sofía | Tudela | Navarra | Spain | |
| 149 | Hospital de Manacor | Manacor | Palma De Mallorca | Spain | |
| 150 | Hospital Álvaro Cunqueiro | Vigo | Pontevedra | Spain | |
| 151 | Hospital de Tortosa Verge de la Cinta | Tortosa | Tarragona | Spain | |
| 152 | Hospital Comarcal de Alcañiz | Alcañiz | Teruel | Spain | |
| 153 | Hospital Lluis Alcanyis | Xàtiva | Valencia | Spain | |
| 154 | Hospital de Galdakao | Galdakao | Vizcaya | Spain | |
| 155 | Hospital Ernest Lluch Martin | Calatayud | Zaragoza | Spain | |
| 156 | Hospital Universitario A Coruña | A Coruña | Spain | ||
| 157 | Hospital General Universitario de Albacete | Albacete | Spain | ||
| 158 | Hospital General Universitario de Alicante | Alicante | Spain | ||
| 159 | Hospital del Mar | Barcelona | Spain | ||
| 160 | Hospital Universitari Sagrat Cor | Barcelona | Spain | ||
| 161 | Hospital Universitario Clínic de Barcelona | Barcelona | Spain | ||
| 162 | Hospital Vall d'Hebrón | Barcelona | Spain | ||
| 163 | Hospital Universitario de Burgos | Burgos | Spain | ||
| 164 | Hospital General Universitario de Ciudad Real | Ciudad Real | Spain | ||
| 165 | Hospital General Virgen de la Luz | Cuenca | Spain | ||
| 166 | Hospital San Pedro de Alcántara | Cáceres | Spain | ||
| 167 | Hospital de la Cruz Roja de Córdoba | Córdoba | Spain | ||
| 168 | Hospital San Juan de Dios | Córdoba | Spain | ||
| 169 | Hospital Universitario Reina Sofía | Córdoba | Spain | ||
| 170 | Hospital Universitari de Girona Dr. Josep Trueta | Gerona | Spain | ||
| 171 | Hospital Universitario Virgen de las Nieves | Granada | Spain | ||
| 172 | Hospital Universitario de Guadalajara | Guadalajara | Spain | ||
| 173 | Hospital de Can Misses | Ibiza | Spain | ||
| 174 | Complejo Hospitalario de Jaén | Jaén | Spain | ||
| 175 | Hospital Universitari Arnau de Vilanova | Lleida | Spain | ||
| 176 | S&H Medical Science Service | Madrid | Spain | 28003 | |
| 177 | Hospital Central de la Defensa Gómez Ulla | Madrid | Spain | ||
| 178 | Hospital de Cantoblanco | Madrid | Spain | ||
| 179 | Hospital General Universitario Gregorio Marañón | Madrid | Spain | ||
| 180 | Hospital Universitario 12 de Octubre | Madrid | Spain | ||
| 181 | Hospital Universitario Clínico San Carlos | Madrid | Spain | ||
| 182 | Hospital Universitario de la Princesa | Madrid | Spain | ||
| 183 | Hospital Universitario Fundación Jiménez Díaz | Madrid | Spain | ||
| 184 | Hospital Universitario Infanta Leonor | Madrid | Spain | ||
| 185 | Hospital Universitario La Paz | Madrid | Spain | ||
| 186 | Hospital Universitario Madrid Sanchinarro | Madrid | Spain | ||
| 187 | Hospital Universitario Ramón y Cajal | Madrid | Spain | ||
| 188 | Hospital General Universitario Morales Meseguer | Murcia | Spain | ||
| 189 | Hospital Universitario Virgen de la Arrixaca | Murcia | Spain | ||
| 190 | Hospital Regional Universitario de Málaga | Málaga | Spain | ||
| 191 | Hospital Universitario Virgen de la Victoria | Málaga | Spain | ||
| 192 | Complexo Hospitalario Universitario de Ourense | Ourense | Spain | ||
| 193 | Complejo Hospitalario de Pontevedra | Pontevedra | Spain | ||
| 194 | Hospital Universitario de Salamanca | Salamanca | Spain | ||
| 195 | Hospital Universitario de Valme | Sevilla | Spain | ||
| 196 | Hospital Universitario Virgen del Rocío | Sevilla | Spain | ||
| 197 | Hospital Virgen Macarena | Sevilla | Spain | ||
| 198 | Hospital Univ. Joan XXIII de Tarragona | Tarragona | Spain | ||
| 199 | Pius Hospital de Valls | Tarragona | Spain | ||
| 200 | Hospital Arnau de Vilanova | Valencia | Spain | ||
| 201 | Hospital Clínico Universitario de Valencia | Valencia | Spain | ||
| 202 | Hospital Universitari i Politècnic La Fe | Valencia | Spain | ||
| 203 | Hospital Universitario Doctor Peset | Valencia | Spain | ||
| 204 | Hospital Clínico Universitario de Valladolid | Valladolid | Spain | ||
| 205 | Hospital Clínico Universitario Lozano Blesa | Zaragoza | Spain | ||
| 206 | Hospital Universitario Miguel Servet | Zaragoza | Spain | ||
| 207 | Hospital Universitario Araba | Vitoria | Álava | Spain | |
| 208 | University Hospital of Geneva | Geneva | Switzerland | ||
| 209 | Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Switzerland | ||
| 210 | Northumbria Healthcare NHS Foundation Trust | Newcastle upon Tyne | Tyne Y Wear | United Kingdom | |
| 211 | Cho Ray Hospital | Ho Chi Minh City | Ho Chi Minh | Vietnam | |
| 212 | Bach Mai Hospital Vietnam Heart Institue | Hanoi | Vietnam | ||
| 213 | Hanoi Medical University Hospital | Hanoi | Vietnam | ||
| 214 | Huu Nghi Hospital | Hanoi | Vietnam | ||
| 215 | Viet Duc Hospital | Hanoi | Vietnam |
Sponsors and Collaborators
- Manuel Monreal
Investigators
- Study Chair: Manuel Monreal, Foundation for the study of VTE diseases. (FUENTE)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Manuel Monreal,
Professor of Internal Medicine,
Foundation for the study of VTE diseases. (FUENTE)
ClinicalTrials.gov Identifier:
NCT02832245
Other Study ID Numbers:
- PIv9042015
First Posted:
Jul 14, 2016
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms: