Information about the Registry

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

Objectives

1. 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.
2. 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.

Patient entry criteria

Participating hospitals enroll all patients that meet predefined eligibility criteria. Patients are included if they have acute deep-vein thrombosis (DVT), pulmonary embolism (PE) and/or superficial venous thrombosis (SVT), confirmed by objective tests (i.e. contrast venography, ultrasonography, impedance plethysmography or magnetic resonance, for suspected DVT; pulmonary angiography, lung scintigraphy or helical computed tomography scan, for suspected PE; ultrasonography for suspected SVT). Patients are excluded if they are currently participating in a therapeutic clinical trial or if they will not be available for a 3-month follow-up.

Study parameters and endpoints

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.

Use of the RIETE study database

Although not intended to influence the routine management of patients participating in the registry, collated data from RIETE are available on the registry's website (www.riete.org) for use by physicians participating, and others in the field. An underlying or coexisting medical condition is selected from a drop-down list and data from the RIETE database are displayed, showing treatments, doses and outcomes of patients with similar clinical profiles. The user can thus compare different therapies and decide which is the most appropriate for their patient, based on previous "real-world" outcomes.

Data management and confidentiality

S & H Medical Science Service is the Coordinating Center for the Registry, with responsibility for all data management activities. Data for each patient are entered on a standard case report form and submitted to the Coordinating Center via the Internet through a secure website. The confidentiality of patient, physician and hospital data is protected prior to data submission by assigning a unique study number to each patient at enrollment, and by deleting or coding all other information that could identify a person or institution. Confidential electronic data are further protected by passwords and all paper copies of data and reports are stored in a secure facility. Data quality is monitored and documented, and a full data audit is performed at periodic intervals.

Members of the Project

Coordinator of the Registry. Dr. Manuel Monreal, Department of Internal Medicine, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

Advisor in epidemiology and statistics. The advice of an expert in epidemiology and statistics, who actively participate in the meetings in which his presence is required, will be available.

Study group. Formed by a representative from each one of the centers participating. In each hospital, this will be the person who directly has the responsibility for the patients with venous thromboembolism who participates, regardless of his/her medical speciality, and/or his/her assignment to one clinical department or another.

Supporting Company. This Project and the website at international level (not in Spain) counts with financial support granted from Bayer Schering Pharma AG.

Finally, what do we pretend with the Registry?

To contribute to the improvement of care of patients with thromboembolic disease. Very often we 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 we should manage these patients and we have to individualize its management. The bibliography available is not of much help. Only if we have a database with a sufficient number of cases we may be able to make evidence based decisions.

This database on the Internet will allow us to consult and obtain an immediate response when taking care of a patient who needs an individualized management. After introducing our patient we will automatically obtain the data of all patients with similar clinical profiles. And this will help us to identify high-risk patients and thus facilitate us preventing possible future complications.

For this purpose, we need the collaboration of all the colleagues interested in venous thromboembolism. The more we are, the more information we will have.

If you wish to join the study Group and be a Member of the Registry, or wish to receive additional information, you may contact:

Coordinating Center for the RIETE Registry

S&H Medical Science Service
C/ Buganvilla 5, 1ºA
28036 Madrid (Spain)
Teléfono: 91 535 71 83
Fax: 91 535 70 52

Electronic mail:
Web: www.shmedical.es

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