Welcome to RIETE Registry
The idea was that if we could put the information of all our patients in a unique database, over time we would be able to learn about the natural history of the disease
The Computerized Registry of Patients with Venous Thromboembolism (RIETE) is a database in the Internet, where we enter clinical information of our patients with venous thromboembolism (VTE).
RIETE was set up in March 2001 in 25 Spanish hospitals. The idea was that if we could put the information of all our patients in a unique database, over time we would be able to learn about the natural history of the disease. This would be particularly useful in VTE patients that are seldom recruited in randomized clinical trials. Thus, we could accede to better information on VTE: clinical characteristics of the patients, treatment, outcomes and long-term sequelae.
Obviously, confidentiality of patients is always guaranteed. All enrollees provide written or verbal informed consent according to the local ethics protocols of enrolling centers. The institutional review board at each enrolling center approves participation in RIETE for the site investigators and allows the entry of de-identified patient information into the RIETE database.
The key data elements
The key data elements in RIETE include demographics, VTE risk factors and co-morbidities (such as presence or absence of immobility, hormonal therapies, pregnancy and puerperal state, recent surgery, active cancer, heart failure, chronic lung disease, renal and liver function, prior VTE, prior bleeding episodes, dementia, depression, autoimmune disorders, gastroduodenal ulcer, inflammatory bowel disease, and others).
It also includes concomitant medications (such as antiplatelet agents, corticosteroids, non-steroidal anti-inflammatory drugs, erythropoietin, statins and psychotropic drugs) and disposition status (inpatient vs. outpatient). Test results (common blood tests [including plasma hematocrit, platelet count, creatinine, and others], cardiac biomarkers [including troponin, CK-MB, and B-type natriuretic peptide], electrocardiogram [including the rhythm, presence of right bundle branch block, S1Q3T3 patter, and others], ultrasonography, echocardiogram, CT-scan), and therapies (including antithrombotic medications, and advanced therapies such as thrombolytic therapy, surgical thrombectomy, and inferior vena caval filter placement) are separately recorded.
The minimum follow-up duration for patients in RIETE is at least 3 months. Since 2010, collaborators have been requested to extend follow-up to at least 12 months. The main outcomes of interest in RIETE include all-cause death, PE-specific death, recurrent DVT, recurrent PE, major bleeding, non-major (but clinically relevant) bleeding, arterial ischemic events (myocardial infarction, ischemic stroke or leg amputation), thrombocytopenia, bone fractures, and other side-effects of the prescribed therapies. In recent years, development of post-thrombotic syndrome (since 2008) and chronic thromboembolic pulmonary hypertension (since 2015) are also ascertained in those with reported long-term follow-up.
Physicians participating in RIETE try to ensure that consecutive patients will be enrolled. Data are recorded on to a computer-based case report form at each participating hospital and submitted to a centralized coordinating center through a secure website. Patients are managed according to the clinical practice of each participating hospital (i.e., there is no standardization of treatment)..
RIETE is an investigator-initiated registry. During the first 5 years, it was supported by Red Respira from the Instituto Carlos III, Spain (Red Respira-ISCiii-RTIC-03/11). It has been also supported by Sanofi Spain in Spain and by Bayer Pharma AG for the rest of the world. There is no payment per recruited patient. The main incentive for patients and investigators participating in RIETE is to generate new knowledge to help for better understanding of VTE epidemiology and outcomes. None of the sponsors have had any role in the design of the registry and do not have rights to access the database, or to review or comment on pre-published studies from RIETE.
Over the years, the number of centers has progressively increased and currently we are in 26 countries, and have data on more than 79,000 patients. With these data we have already published 169 scientific articles in specialized medical journals.
The key data elements in RIETE include demographics, VTE risk factors and co-morbidities
The main incentive for patients and investigators participating in RIETE is to generate new knowledge to help for better understanding of VTE epidemiology and outcomes
The RIETE Registry is the world’s largest database on patients with venous thromboembolism (VTE).
RIETE Registry is a Fundación Fuente project