Computerized Registry of Patients With Venous Thromboembolism (RIETE)

Overview

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.

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.

Primary outcome measures

• VTE events and complications [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Other

Study locations

Spain · 138 centers

Center list to be confirmed — check the primary protocol.

Italy · 29 centers

• Ospedale SS. Filippo e Nicola — Avezzano
• ULSS 1 Dolomiti — Belluno
• Spedali Civili di Brescia — Brescia
• AORN San Giuseppe Moscati Avellino — Avellino
• Ospedale Buon Consiglio Fatebenefratelli — Naples
• Hospital of Marcianise — Marcianise
• Ospedale CastelFranco Veneto — Castelfranco
• Istituti Ospitalieri di Cremona — Cremona
• … and 21 more centers

France · 19 centers

• University Hospital Jean Minjoz — Besançon
• CHRU Brest — Brest
• Clermont-Ferrand University Hospital — Clermont-Ferrand
• Hôpital Louis Mourier — Colombes
• CHU de Dijon Bourgogne — Dijon
• Hôpital Édouard Herriot — Lyon
• Médipôle Hôpital Mutualiste — Villeurbanne
• Hôpital de la Timone — Marseille
• … and 11 more centers

Japan · 9 centers

Center list to be confirmed — check the primary protocol.

United States · 6 centers

• Yale University School of Medicine — New Haven
• College of Medicine - Jacksonville University of Florida — Jacksonville
• Evanston NorthShore University HealthSystem — Evanston
• Massachusetts General Hospital — Boston
• Northwell Health System — Manhasset
• Medical College of Wisconsin — Milwaukee

Iran · 6 centers

• Imam Reza Hospital — Tabriz
• Abu-Ali- Sina Organ Transplant Center (OCT) — Shiraz
• Chamran Cardiology Hospital — Isfahan
• Masih-Daneshvari Hospital — Tehran
• Rajaie Cardiovascular Medical and Research Center — Tehran
• Tehran Heart Center — Tehran

Portugal · 6 centers

Center list to be confirmed — check the primary protocol.

Vietnam · 5 centers

Center list to be confirmed — check the primary protocol.

Brazil · 4 centers

• Hospital Jorge Valente — Salvador
• Hospital Glória d'Or — Rio de Janeiro
• Hospital Cardio Pulmonar — Salvador
• Botucatu Medical School - São Paulo State University (UNESP) — Botucatu

Colombia · 4 centers

• Hospital Universitario San Vicente Fundación — Medellín
• Hospital Universitario Fundación Santa Fé de Bogota — Bogotá
• Hospital Universitario Fundación Valle del Lili — Cali
• Hospital Universitario San José de Buga Fundación — Guadalajara de Buga

Israel · 4 centers

• Rambam Healthcare Campus — Haifa
• Galilee Medical Center — Nahariya
• Hematology Institute of ZIV Medical Center — Safed
• Sheba Medical Center — Ramat Gan

Argentina · 3 centers

• Clínica San Camilo — Buenos Aires
• Hospital Italiano de Buenos Aires — Buenos Aires
• Clínica Privada Pueyrredón — Mar del Plata

Czechia · 3 centers

• University Hospital Hradec Kralove — Hradec Králové
• Hospital Pardubická Krasjská Nemocnice A.S. — Pardubice
• University Hospital Plzen — Pilsen

Ecuador · 3 centers

• Hospital Luis Vernaza — Guayaquil
• Hospital Clínica La Merced — Quito
• Hospital SOLCA Núcleo de Quito — Quito

Switzerland · 3 centers

Center list to be confirmed — check the primary protocol.

China · 2 centers

• The Seven Medical Center of Chinese PLA General Hospital — Beijing
• Peking University Cancer Hospital and Institute — Beijing

North Macedonia · 2 centers

Center list to be confirmed — check the primary protocol.

Austria · 1 center

• Medical University of Vienna — Vienna

Belgium · 1 center

• Hospital UZ Leuven — Leuven

Egypt · 1 center

• Ain Shams University Specialized Hospital — Cairo

Germany · 1 center

• Municipal Hospital of Dresden Friedrichstadt — Dresden

Greece · 1 center

• Hospital Papageorgiou — Thessaloniki

Honduras · 1 center

• Hospital Escuela Universitario — Tegucigalpa

Ireland · 1 center

• Mater Misericordiae University Hospital — Dublin

Latvia · 1 center

Center list to be confirmed — check the primary protocol.

Mexico · 1 center

Center list to be confirmed — check the primary protocol.

Morocco · 1 center

Center list to be confirmed — check the primary protocol.

United Kingdom · 1 center

Center list to be confirmed — check the primary protocol.

Publications

• Espitia O, Guedon AF, Courouve E, Brenner B, Lopez-Nunez JJ, Chopard R, Lorenzo A, Siguenza P, Truong Nguyen S, Monreal M; RIETE Investigators. Upper Extremity Deep Vein Thrombosis in Cancer Patients: Clinical Course by Cancer Site. JACC CardioOncol. 2026 Jun;8(3):266-278. doi: 10.1016/j.jaccao.2026.05.008. PMID 42307153
• Jimenez D, Yusen RD, Velasco JM, Morillo R, Muriel A, Jara-Palomares L, Bertoletti L, Hernandez-Blasco LM, Gil-Diaz A, Moustafa F, Fidalgo A, Sadeghipour P, Pham KQ, Bikdeli B, Monreal M; RIETE Investigators. Oxygen saturation and mortality for acute pulmonary embolism: multinational retrospective cohort study. EClinicalMedicine. 2026 Apr 16;94:103889. doi: 10.1016/j.eclinm.2026.103889. eCollectio PMID 42077645
• Cohen O, Waldman Radinsky L, Kenet G, Mahe I, Barillari G, Soler S, Siguenza P, Del Valle Morales M, Villares P, Monreal M. Venous thromboembolism characteristics and outcomes among RIETE patients tested and untested for inherited thrombophilia. Blood Adv. 2024 Sep 24;8(18):4950-4959. doi: 10.1182/bloodadvances.2024012611. PMID 38669351
• Bertoletti L, Madridano O, Jimenez D, Muriel A, Bikdeli B, Ay C, Trujillo-Santos J, Bosevski M, Siguenza P, Monreal M. Cancer-Associated Thrombosis: Trends in Clinical Features, Treatment, and Outcomes From 2001 to 2020. JACC CardioOncol. 2023 Nov 15;5(6):758-772. doi: 10.1016/j.jaccao.2023.09.003. eCollection 2023 Dec. PMID 38205016
• Martin Romero M, Salazar Rosa V, Demelo Rodriguez P, Visona A, Farfan Sedano AI, Peris Sifre ML, Skride A, Usandizaga E, Meireles J, Monreal M. Clinical characteristics and outcomes in patients with retinal vein occlusion. Vasc Med. 2022 Dec;27(6):590-592. doi: 10.1177/1358863X221122505. Epub 2022 Sep 30. No abstract available. PMID 36178134
• Prandoni P, Pesavento R, Bilora F, Fernandez Reyes JL, Madridano O, Soler S, Monreal M. No difference in outcome between therapeutic and preventive anticoagulation in patients with superficial vein thrombosis involving the saphenous-femoral junction. Vasc Med. 2022 Jun;27(3):290-292. doi: 10.1177/1358863X211066962. Epub 2022 Jan 30. No abstract available. PMID 35098818
• Bikdeli B, Moustafa F, Nieto JA, Lee AI, Ruiz-Gimenez N, Lorenzo A, Schellong S, Soler S, Ortiz S, Morales MDV, Bosevski M, Gavin O, Lip GYH, Monreal M; RIETE Investigators. Clinical characteristics, time course, and outcomes of major bleeding according to bleeding site in patients with venous thromboembolism. Thromb Res. 2022 Mar;211:10-18. doi: 10.1016/j.thromres.2022.01.007. Epub 2022 Jan 14. PMID 35051831
• Martinez-Urbistondo D, de la Garza RG, Villares-Fernandez P, Font C, Schellong S, Lopez-Nunez JJ, Gil-Diaz A, Del Carmen Diaz-Pedroche M, Hirmerova J, Monreal M; RIETE Investigators. Liver status and outcomes in patients without previous known liver disease receiving anticoagulant therapy for venous thromboembolism. Intern Emerg Med. 2022 Apr;17(3):725-734. doi: 10.1007/s11739-021-02858-x. Epub 20 PMID 34626318

Identifiers

NCT: NCT02832245 · PIv9042015

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗