Institutional Registry of Thromboembolic Disease (IRTD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01372514
Recruitment Status : Recruiting
First Posted : June 14, 2011
Last Update Posted : December 17, 2015
Information provided by (Responsible Party):
Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires

June 10, 2011
June 14, 2011
December 17, 2015
August 2006
January 2020   (Final data collection date for primary outcome measure)
Incidence [ Time Frame: 4 years ]
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Complete list of historical versions of study NCT01372514 on Archive Site
evaluate new hypothesis [ Time Frame: yearly ]
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Institutional Registry of Thromboembolic Disease
Institutional Registry of Thromboembolic Disease

The purpose of this study is to create an institutional registry of Thromboembolic disease through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

The main goal is to describe the occurrence of thromboembolic disease and the characteristics of clinical presentation, evolution and predisposing factors of these episodes in the population of the Hospital Italiano de Buenos Aires.

Deep Vein Thrombosis (DVT) and pulmonary thromboembolism (PTE) are the most common clinical manifestations of thromboembolic disease (TD). The PTE is one of the most important preventable causes of death in hospitalized patients, with a mortality up to 17% in a 3 month period. During the past 20 years important changes have been made in terms of clinical awareness, diagnostic tools and treatment.

No data has been found in our country which shows the TD population incidence. According to WHO, the sex-specific mortality rate associated to TD in Argentina in the year 2001 (including DVT and PE coded by ICD10), estimated by epidemiological death records was 0.2 / 100,000 for men and 0, 5 / 100000 for women (based on 37 and 87 cases respectively). This seems to represent a clear report deficiency.

Registries are systematic surveys which are found in a database. They function as monitoring lists and allow epidemiological evaluations of the affected patients. Several methods can be found to diagnose thromboembolic disease. These include OPTIMEV: Interrogatoire Optimisation de l'évaluation du risque dans l'Maladie ThromboEmbolique of Veineuse (its aim is to include about 10000 cases of suspected DT); MAPPET: Management Strategy and Prognosis of Pulmonary Embolism Registry (its goal is to include 1001 consecutive patients with PE), ICOPER: International Cooperative Pulmonary Embolism Registry (to include 2454 consecutive patients with PE), DVT FREE (including TVP 5451),RIETE: Computerized Patient Record venous thromboembolism in Spain (to register patients with DVT or PE).

No published records have been found regarding the approach used for diagnosis and treatment of suspected PTE patients in our country. Moreover, no publications on systematic epidemiological data (risk factors, assessment and follow-up survival, complications and recurrences)were found.

The registry of suspected TD cases will allow us to distinguish the disease characteristics in our community, the most used diagnostic strategies, the results and the pathology evolution in time.

The Hospital Italiano counts with computerized clinical records which provide incidence, morbidity and mortality data.

It is our belief that this registry will allow us to design studies to improve and standardize the most used diagnostic strategies.

Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
The eligible population is all patients equal or older than 17 years, evaluated and followed in the Hospital Italiano de Buenos Aires, with an episode of pulmonary embolism suspected by the medical examiner or confirmed diagnosis of DVT or PE. The aim is to include the entire population that meets the criteria for inclusion and no exclusion.
  • Thromboembolism
  • Venous Thromboembolism
  • Pulmonary Embolism
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suspected thromboembolic disease
Patients with thromboembolic disease according to diagnostic tests (MDTC with angiography, scintigraphy V/Q, dimer d, ecografia doppler, etc. ) required by the physician.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2020
January 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Equal to or older than 17 years.
  • Followed in HIBA.
  • Suspected pulmonary embolism or diagnosed venous thrombosis

Exclusion Criteria:

  • Patient with monitoring and care at another facility who only attend the hospital to use its diagnostic method.
  • Patient's refusal to participate in the registry or informed consent process.
Sexes Eligible for Study: All
17 Years and older   (Child, Adult, Older Adult)
Contact: Diego H Giunta, MD 005411-49590200 ext 4419
Contact: Lourdes M Posadas-Martínez, MD 005411-49590200 ext 4419
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Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
Hospital Italiano de Buenos Aires
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Principal Investigator: Diego H Giunta, MD Internal Medicine Clinical research Area Coordinator
Study Director: Fernan Gonzales Bernaldo de Quirós, MD Internal Medicine Clinical Research Area Chief
Study Chair: Fernando Vazquez, MD Internal Medicine Staff
Study Chair: Lourdes Posadas-MArtínez, MD Internal Medicine Clinical research Area , HIBA
Hospital Italiano de Buenos Aires
December 2015