Computerized Registry of Patients With Venous Thromboembolism (RIETE) (RIETE)

• ClinicalTrials.gov Identifier: NCT02832245
• Recruitment Status: Recruiting
• First Posted: July 14, 2016
• Last Update Posted: July 15, 2019
• Sponsor: Manuel Monreal
• Information provided by (Responsible Party): Manuel Monreal, Foundation for the study of VTE diseases. (FUENTE)

Study Description

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.

Condition or disease
Venous Thromboembolism

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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 90000 participants
• Observational Model: Other
• Time Perspective: Prospective
• Target Follow-Up Duration: 3 Years
• Official Title: Computerized Registry of Patients With Venous Thromboembolism (RIETE)
• Study Start Date: March 2001
• Estimated Primary Completion Date: December 2026
• Estimated Study Completion Date: December 2027

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. VTE events and complications [ Time Frame: 3 years ]
   Study endpoints are clinically recognized (and objectively confirmed) recurrences of VTE, major and minor bleeding complications, and death.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with Venous Thromboembolism

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

Contacts and Locations

Contacts

Contact: Mayra Hawkins; 0034915357183; riete@shmedical.es

Locations

Spain

S&H Medical Science Service; Recruiting

Madrid, Spain, 28003

Contact: Mayra Hawkins 0034649686297

Sponsors and Collaborators

Manuel Monreal

More Information

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jiménez D, Bikdeli B, Quezada A, Muriel A, Lobo JL, de Miguel-Diez J, Jara-Palomares L, Ruiz-Artacho P, Yusen RD, Monreal M; RIETE investigators. Hospital volume and outcomes for acute pulmonary embolism: multinational population based cohort study. BMJ. 2019 Jul 29;366:l4416. doi: 10.1136/bmj.l4416.

Mellado M, Trujillo-Santos J, Bikdeli B, Jiménez D, Núñez MJ, Ellis M, Marchena PJ, Vela JR, Clara A, Moustafa F, Monreal M; RIETE Investigators. Vena cava filters in patients presenting with major bleeding during anticoagulation for venous thromboembolism. Intern Emerg Med. 2019 May 3. doi: 10.1007/s11739-019-02077-5. [Epub ahead of print] Erratum in: Intern Emerg Med. 2019 Jun 20;:.

• Responsible Party: Manuel Monreal, Professor of Internal Medicine, Foundation for the study of VTE diseases. (FUENTE)
• ClinicalTrials.gov Identifier: NCT02832245 History of Changes
• Other Study ID Numbers: PIv9042015
• First Posted: July 14, 2016
• Last Update Posted: July 15, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Thromboembolism; Venous Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases