Computerized Registry of Patients With Venous Thromboembolism (RIETE)

Recruiting

• Conditions: Venous Thromboembolism

• Registration Number: NCT02832245
• Lead Sponsor: Manuel Monreal

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.

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 Timeline

• Study Start: 2001-03
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VTE events and complications	3 years	Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.

Trial Locations

Locations (250)

Ospedale Santa Chiara di Trento; 🇮🇹 Trento, Italy

Hospital Universitari General de Catalunya; 🇪🇸 Sant Cugat Del Vallès, Barcelona, Spain

Hospital Universitari Son Espases; 🇪🇸 Palma, Illes Balears, Spain

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

College of Medicine - Jacksonville University of Florida; 🇺🇸 Jacksonville, Florida, United States

Evanston NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Northwell Health System; 🇺🇸 Manhasset, New York, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Clínica Privada Pueyrredón; 🇦🇷 Mar Del Plata, Buenos Aires, Argentina

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