Recruiting

Observational Study

Sponsor:

Manuel Monreal

Code:

NCT02832245

Conditions

Venous Thromboembolism

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Venous Thromboembolism

Study ID

NCT02832245

Start date

Mar, 2001

Status verified date

May, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

120000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

College of Medicine - Jacksonville University of Florida

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Principal Investigator:

Luis Ortega Paz

Evanston NorthShore University HealthSystem

Recruiting

Evanston, Illinois, United States, 60201

Principal Investigator:

Alfonso Tafur

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Gaurav M Parmar

More Information

Sponsor

Manuel Monreal

Last update posted

Sep 24, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Manuel Monreal on 2025-09-24.