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

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ClinicalTrials.gov Identifier: NCT02832245
Recruitment Status : Recruiting
First Posted : July 14, 2016
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Manuel Monreal, Foundation for the study of VTE diseases. (FUENTE)

Tracking Information
First Submitted Date July 6, 2016
First Posted Date July 14, 2016
Last Update Posted Date May 11, 2021
Study Start Date March 2001
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2016)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Computerized Registry of Patients With Venous Thromboembolism (RIETE)
Official Title Computerized Registry of Patients With Venous Thromboembolism (RIETE)
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 Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Venous Thromboembolism
Condition Venous Thromboembolism
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 7, 2021)
120000
Original Estimated Enrollment
 (submitted: July 11, 2016)
90000
Estimated Study Completion Date December 2027
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Mayra Hawkins 0034915357183 riete@shmedical.es
Listed Location Countries Argentina,   Austria,   Belgium,   Brazil,   China,   Czechia,   Ecuador,   Egypt,   France,   Germany,   Greece,   Honduras,   Iran, Islamic Republic of,   Ireland,   Israel,   Italy,   Japan,   Latvia,   North Macedonia,   Portugal,   Spain,   Switzerland,   United States,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT02832245
Other Study ID Numbers PIv9042015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Manuel Monreal, Foundation for the study of VTE diseases. (FUENTE)
Study Sponsor Manuel Monreal
Collaborators Not Provided
Investigators
Study Chair: Manuel Monreal Foundation for the study of VTE diseases. (FUENTE)
PRS Account Foundation for the study of VTE diseases. (FUENTE)
Verification Date May 2021