Computerized Registry of Patients With Venous Thromboembolism (RIETE)

Venous Thromboembolism Clinical Trial

— RIETE  

Official title:

Computerized Registry of Patients With Venous Thromboembolism (RIETE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02832245
• Other study ID #: PIv9042015
• Status: Recruiting
• Start date: March 2001
• Est. completion date: December 2027

Study information

• Verified date: February 2024
• Source: Foundation for the study of VTE diseases. (FUENTE)
• Contact: Mayra Hawkins
• Phone: 0034915357183
• Email: riete[@]shmedical.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120000
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Argentina	Clínica San Camilo	Buenos Aires
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Clínica Privada Pueyrredón	Mar Del Plata	Buenos Aires
Austria	Medical University of Vienna	Vienna
Belgium	Hospital UZ Leuven	Leuven
Brazil	Botucatu Medical School - São Paulo State University (UNESP)	Botucatu	São Paulo
Brazil	Hospital Glória d'Or	Rio De Janeiro
Brazil	Hospital Cardio Pulmonar	Salvador
Brazil	Hospital Jorge Valente	Salvador De Bahía	Bahía
China	Peking University Cancer Hospital and Institute	Beijing	Beijing
Colombia	Hospital Universitario Fundación Santa Fé de Bogota	Bogotá
Colombia	Hospital Universitario San José de Buga Fundación	Guadalajara de Buga	Valle Del Cauca
Colombia	Hospital Universitario San Vicente Fundación	Medellín	Antioquia
Czechia	University Hospital Hradec Kralove	Hradec Králové
Czechia	University Hospital Plzen	Plzen
Ecuador	Hospital Luis Vernaza	Guayaquil	Guayas
Ecuador	Hospital Clínica La Merced	Quito
Ecuador	Hospital SOLCA Núcleo de Quito	Quito
Egypt	Ain Shams University Specialized Hospital	Cairo
France	Hospital Center of Avignon	Avignon	Provenza
France	Institut Sainte Catherine	Avignon	Provenza
France	University Hospital Jean Minjoz	Besançon
France	CHRU Brest	Brest
France	Clermont-Ferrand University Hospital	Clermont-Ferrand
France	Hôpital Louis Mourier	Colombes
France	CHU de Dijon Bourgogne	Dijon
France	Hôpital Édouard Herriot	Lyon
France	Hôpital de la Timone	Marseille
France	Hôpital Saint Eloi	Montpellier
France	CHU Nantes	Nantes
France	Hôpital Europeen Georges Pompidou	Paris
France	Hôpital Lariboisiere	Paris
France	Hôpital Paris Saint-Joseph	Paris
France	Hôpital Saint-Louis	Paris
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Hôpital Nord - CHU St-Etienne	Saint-Étienne	Saint-Etienne
France	Hôpital de Rangueil	Toulouse
France	Médipôle Hôpital Mutualiste	Villeurbanne	Lyon
Germany	Municipal Hospital of Dresden Friedrichstadt	Dresden
Greece	Hospital Papageorgiou	Salónica	Saloniki
Honduras	Hospital Escuela Universitario	Tegucigalpa
Iran, Islamic Republic of	Chamran Cardiology Hospital	Isfahan
Iran, Islamic Republic of	Abu-Ali- Sina Organ Transplant Center (OCT)	Shiraz	Fars
Iran, Islamic Republic of	Imam Reza Hospital	Tabriz	Azerbaiyán Oriental
Iran, Islamic Republic of	Masih-Daneshvari Hospital	Tehran
Iran, Islamic Republic of	Rajaie Cardiovascular Medical and Research Center	Tehran
Iran, Islamic Republic of	Tehran Heart Center	Tehran
Ireland	Mater Misericordiae University Hospital	Dublin	Leinster
Israel	Rambam Healthcare Campus	Haifa
Israel	Galilee Medical Center	Nahariya
Israel	Sheba Medical Center	Ramat Gan	Tel Hashomer
Israel	Hematology Institute of ZIV Medical Center	Safed
Italy	AORN San Giuseppe Moscati Avellino	Avellino	Campania
Italy	Ospedale SS. Filippo e Nicola	Avezzano	L'Aquila
Italy	ULSS 1 Dolomiti	Belluno
Italy	Ospedale CastelFranco Veneto	Castelfranco	Castelfranco Veneto
Italy	Istituti Ospitalieri di Cremona	Cremona
Italy	Ospedale Galliera	Genoa	Genova
Italy	Hospital of Marcianise	Marcianise	Caserta
Italy	A.O.U Policlinico "G. Martino"	Messina
Italy	IRCCS Istituto Auxologico Italiano	Milan
Italy	Federico II University Hospital	Naples
Italy	Ospedale Buon Consiglio Fatebenefratelli	Naples	Campania
Italy	University of Padua	Padua	Veneto
Italy	Azienda Ospedaliera Universitaria di Parma	Parma
Italy	Presidio Ospedaliero Santa Maria Delle Grazie	Pozzuoli	Naples
Italy	Azienda U.S.L. Di Ravenna - O.C. Di Faenza	Ravenna
Italy	Hospital Rieti	Rieti
Italy	Ospedale Infermi	Rimini
Italy	"A. Gemelli " Hospital	Rome
Italy	Ospedale San Camillo	Rome
Italy	Ospedale St. John	Rome
Italy	Istituto Clinico Humanitas IRCCS	Rozzano	Milan
Italy	Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Foggia
Italy	Azienda ULSS 7 Pedemontana Regione Veneto	Santorso	Vicenza
Italy	Ospedale Santa Maria della Misericordia	Udine
Italy	Università dell´Insubria	Varese
Italy	Ospedale SS. Giovanni e Paolo di Venezia	Venice
Japan	Hyogo Prefectural Amagasaki General Medical Center	Amagasaki	Hyogo
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kyoto University Hospital	Kyoto
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	Nagasaki University Hospital	Nagasaki
Japan	Osaka Saiseikai Noe Hospital	Osaka
Japan	Mie University Hospital	Tsu	Mie
Japan	Japanese Red Cross Wakayama Medical Center	Wakayama
Latvia	Pauls Stradins Clinical University Hospital	Riga
Morocco	Ibn Sina Hospital	Rabat
North Macedonia	PHI University Clinic of Pulmology and Allergy Skopje	Skopje
North Macedonia	University Cardiology Clinic	Skopje
Portugal	Hospital García de Orta	Almada	Setúbal
Portugal	Hospital General de Santo Antonio Porto	Porto
Portugal	Unidade Local de Saúde Entre Douro e Vouga	Santa Maria Da Feira	Santa María Da Feira
Portugal	Hospital Pedro Hispano - Unidade Local de Saúde de Matosinhos	Senhora Da Hora	Matosinhos
Portugal	Centro Hospitalar do Médio Ave	Vila Nova De Famalicão	Famalicão
Portugal	Centro Hospitalar Gaia/Espinho, EPE	Vila Nova De Gaia
Spain	Hospital Universitario A Coruña	A Coruña
Spain	Hospital General Universitario de Albacete	Albacete
Spain	Hospital Comarcal de Alcañiz	Alcañiz	Teruel
Spain	Fundación Hospital Alcorcón	Alcorcón	Madrid
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital del Tajo	Aranjuez	Madrid
Spain	Hospital Doctor José Molina Orosa	Arrecife	Lanzarote
Spain	Hospital Municipal de Badalona	Badalona	Barcelona
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Universitario Cruces	Barakaldo	Vizcaya
Spain	Hospital de Sant Celoni	Barcelona	Barceona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Sagrat Cor	Barcelona
Spain	Hospital Universitario Clínic de Barcelona	Barcelona
Spain	Hospital Vall d'Hebrón	Barcelona
Spain	Hospital Universitario HM Monteprincipe	Boadilla del Monte	Madrid
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Infanta Margarita	Cabra	Córdoba
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hospital Universitario Puerta del Mar	Cadiz	Cádiz
Spain	Hospital Ernest Lluch Martin	Calatayud	Zaragoza
Spain	Hospital General Universitario Santa Lucía	Cartagena	Murcia
Spain	Consorcio Hospitalario Provincial de Castellón	Castellón De La Plana	Castellón
Spain	Hospital General Universitari de Castelló	Castellón De La Plana	Castellón
Spain	Hospital General Universitario de Ciudad Real	Ciudad Real
Spain	Hospital de la Cruz Roja de Córdoba	Córdoba
Spain	Hospital San Juan de Dios	Córdoba
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Monográfico ASEPEYO	Coslada	Madrid
Spain	Hospital General Virgen de la Luz	Cuenca
Spain	Hospital de Poniente	El Ejido	Almería
Spain	Hospital El Vendrell	El Vendrell	Tarragona
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital Universitario de Vinalopó	Elche	Alicante
Spain	Hospital General Universitario de Elda	Elda	Alicante
Spain	Complejo Hospitalario Universitario de Ferrol	Ferrol	A Coruña
Spain	Hospital de Figueres	Figueres	Gerona
Spain	Hospital Universitario de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital de Galdakao	Galdakao	Vizcaya
Spain	Hospital Universitari de Girona Dr. Josep Trueta	Gerona
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Hospital Universitario de Cabueñes	Gijón	Asturias
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital General de Granollers	Granollers	Barcelona
Spain	Hospital Universitario de Guadalajara	Guadalajara
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital de Can Misses	Ibiza
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital del Alto Guadalquivir Andújar	Jaén	Jaen
Spain	Hospital Jerez de la Frontera	Jerez De La Frontera	Cádiz
Spain	Hospital Valle del Nalón	Langreo	Asturias
Spain	Complejo Hospitalario Insular-Materno Infantil	Las Palmas De Gran Canaria	Las Palmas
Spain	Hospital Universitario de Gran Canaria Dr. Negrín	Las Palmas De Gran Canaria	Las Palmas
Spain	Hospital Universitari Arnau de Vilanova	Lleida
Spain	Hospital San Pedro	Logroño	La Rioja
Spain	Hospital Rafael Méndez de Lorca	Lorca	Murcia
Spain	Hospital Central de la Defensa Gómez Ulla	Madrid
Spain	Hospital de Cantoblanco	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Clínico San Carlos	Madrid
Spain	Hospital Universitario de la Princesa	Madrid
Spain	Hospital Universitario Fundación Jiménez Díaz	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Madrid Sanchinarro	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Vithas Madrid La Milagrosa	Madrid
Spain	S&H Medical Science Service	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitario Virgen de la Victoria	Málaga
Spain	Hospital de Manacor	Manacor	Palma De Mallorca
Spain	Althaia, Xarxa Assistencial Universitària de Manresa	Manresa	Barcelona
Spain	Consorci Hospitalari de Mataró	Mataró	Barcelona
Spain	Hospital de Montilla	Montilla	Córdoba
Spain	Hospital Universitario de Móstoles	Móstoles	Madrid
Spain	Hospital Universitario Rey Juan Carlos	Móstoles	Madrid
Spain	Hospital General Universitario Morales Meseguer	Murcia
Spain	Hospital General Universitario Reina Sofía	Murcia
Spain	Hospital Universitario Virgen de la Arrixaca	Murcia
Spain	Hospital d'Olot i Comarcal de la Garrotxa	Olot	Gerona
Spain	Hospital Vega Baja	Orihuela	Alicante
Spain	Complexo Hospitalario Universitario de Ourense	Ourense
Spain	Hospital de Palamós	Palamós	Gerona
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario de Navarra	Pamplona	Navarra
Spain	Complejo Hospitalario de Pontevedra	Pontevedra
Spain	Hospital Universitario Puerto Real	Puerto Real	Cádiz
Spain	Hospital Santa Bárbara	Puertollano	Ciudad Real
Spain	Hospital Comarcal de Barbanza	Ribeira	A Coruña
Spain	Corporación Sanitaria Parc Taulí	Sabadell	Barcelona
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario de Donostia	San Sebastián	Guipúzcoa
Spain	Hospital Universitario Infanta Sofía	San Sebastián De Los Reyes	Madrid
Spain	Parc Sanitari Sant Joan de Deu	Sant Boi De Llobregat	Barcelona
Spain	Hospital Universitario General de Cataluña	Sant Cugat Del Vallès	Barcelona
Spain	Hospital Sant Joan Despí-Moisés Broggi	Sant Joan Despí	Barcelona
Spain	Hospital Sant Camil	Sant Pere De Ribes	Barcelona
Spain	Fundació Hospital del L'Esperit Sant	Santa Coloma De Gramenet	Barcelona
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Clínico Universitario de Santiago	Santiago De Compostela	A Coruña
Spain	Hospital Universitario de Valme	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Virgen Macarena	Sevilla
Spain	Hospital Univ. Joan XXIII de Tarragona	Tarragona
Spain	Pius Hospital de Valls	Tarragona
Spain	Hospital Universitario Mutua Terrassa	Terrassa	Barcelona
Spain	Hospital Sierrallana	Torrelavega	Cantabria
Spain	Hospital Universitario de Torrevieja	Torrevieja	Alicante
Spain	Hospital de Tortosa Verge de la Cinta	Tortosa	Tarragona
Spain	Hospital Reina Sofía	Tudela	Navarra
Spain	Hospital Arnau de Vilanova	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politècnic La Fe	Valencia
Spain	Hospital Universitario Doctor Peset	Valencia
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Comarcal de la Axarquía	Vélez-Málaga	Malaga
Spain	Hospital Álvaro Cunqueiro	Vigo	Pontevedra
Spain	Hospital Comarcal de L'Alt Penedés	Vilafranca Del Penedès	Barcelona
Spain	Hospital Universitario Araba	Vitoria	Álava
Spain	Hospital Lluis Alcanyis	Xàtiva	Valencia
Spain	Hospital Virgen del Castillo	Yecla	Murcia
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza
Spain	Hospital de Zumarraga	Zumarraga	Guipúzcoa
Switzerland	University Hospital of Geneva	Geneva
Switzerland	Centre Hospitalier Universitaire Vaudois (CHUV)	Lausanne
Switzerland	University Hospital Zurich	Zurich
United Kingdom	Northumbria Healthcare NHS Foundation Trust	Newcastle upon Tyne	Tyne Y Wear
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Evanston NorthShore University HealthSystem	Evanston	Illinois
United States	College of Medicine - Jacksonville University of Florida	Jacksonville	Florida
United States	Northwell Health System	Manhasset	New York
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Yale University School of Medicine	New Haven	Connecticut
Vietnam	Bach Mai Hospital Vietnam Heart Institue	Hanoi
Vietnam	Hanoi Medical University Hospital	Hanoi
Vietnam	Huu Nghi Hospital	Hanoi
Vietnam	Viet Duc Hospital	Hanoi
Vietnam	Cho Ray Hospital	Ho Chi Minh City	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Manuel Monreal

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Austria,  Belgium,  Brazil,  China,  Colombia,  Czechia,  Ecuador,  Egypt,  France,  Germany,  Greece,  Honduras,  Iran, Islamic Republic of,  Ireland,  Israel,  Italy,  Japan,  Latvia,  Morocco,  North Macedonia,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE events and complications	Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.	3 years