Clinical trial NCT01372514: Institutional Registry of Thromboembolic Disease
Official title: Institutional Registry of Thromboembolic Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thromboembolism
Venous Thromboembolism
Pulmonary Embolism
Keywords: Thromboembolism
Venous Thromboembolism
Pulmonary Embolism
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2011-06-14
Enrollment: 4500
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence
timeFrame: 4 years
Secondary outcomes:
measure: evaluate new hypothesis
timeFrame: yearly
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
Study officials:
affiliation: Internal Medicine Clinical research Area Coordinator
name: Diego H Giunta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Internal Medicine Clinical Research Area Chief
name: Fernan Gonzales Bernaldo de Quirós, MD
role: STUDY_DIRECTOR
affiliation: Internal Medicine Staff
name: Fernando Vazquez, MD
role: STUDY_CHAIR
affiliation: Internal Medicine Clinical research Area , HIBA
name: Lourdes Posadas-MArtínez, MD
role: STUDY_CHAIR
References:
citation: Grande Ratti MF, Posadas-Martinez ML, Vicens J, Gonzalez Bernaldo de Quiros F, Vazquez FJ, Giunta DH. Incidence of hospital-acquired venous thromboembolic disease. Rev Fac Cien Med Univ Nac Cordoba. 2018 Jun 12;75(2):82-87. doi: 10.31053/1853.0605.v75.n2.17243.
citation: Vazquez FJ, Posadas-Martinez ML, de Quiros FG, Giunta DH. Prognosis of patients with suspected pulmonary embolism in Buenos Aires: a prospective cohort study. BMC Pulm Med. 2014 Dec 15;14:200. doi: 10.1186/1471-2466-14-200.
citation: Angriman F, Ferreyro BL, Posadas-Martinez ML, Giunta D, Vazquez FJ, Vollmer WM. Wells Score and Poor Outcomes Among Adult Patients With Subsegmental Pulmonary Embolism: A Cohort Study. Clin Appl Thromb Hemost. 2015 Sep;21(6):539-45. doi: 10.1177/1076029614559772. Epub 2014 Nov 25.
citation: Ferreyro BL, Angriman F, Giunta D, Posadas-Martinez ML, Vazquez F, De Quiros FG, Amaral AC, Scales DC. Predictive score for estimating cancer after venous thromboembolism: a cohort study. BMC Cancer. 2013 Jul 22;13:352. doi: 10.1186/1471-2407-13-352.