ThromboembolismIRTDNCT01372514
Institutional Registry of Thromboembolic Disease
An observational study of Thromboembolism and Venous Thromboembolism, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Thromboembolism, Venous Thromboembolism, Pulmonary Embolism
- How many people
- 4,500 participants
- Where
- 1 siteArgentina
- Study dates
- Aug 2006to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Equal to or older than 17 years.
- Followed in HIBA.
- Suspected pulmonary embolism or diagnosed venous thrombosis
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lourdes M Posadas-Martínez, MD contact
Argentina1 site, 1 recruiting
- Recruiting
Hospital Italiano
Buenos Aires
Diego H Giunta, MD, 005411-49590200 ext. 4419, diego.giunta@hospitalitaliano.org.ar
Cristina M Elizondo, MD, 005411-49590200 ext. 4419, cristina.elizondo@hospitalitaliano.org.ar
About this study
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.
Read the 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.
- Conditions
- Thromboembolism, Venous Thromboembolism, Pulmonary Embolism
- Keywords
- Thromboembolism, Venous Thromboembolism, Pulmonary Embolism
- Medical subject headings
- Thromboembolism, Venous Thromboembolism, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
Measured: 4 years
Secondary outcomes (1)
evaluate new hypothesis
Measured: yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startAug 2006
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
- Investigators
- Diego H Giunta, MD, Principal investigator, Internal Medicine Clinical research Area CoordinatorFernan Gonzales Bernaldo de Quirós, MD, Study director, Internal Medicine Clinical Research Area ChiefFernando Vazquez, MD, Study chair, Internal Medicine StaffLourdes Posadas-MArtínez, MD, Study chair, Internal Medicine Clinical research Area , HIBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372514
- Sponsor's protocol ID
- 995
- Acronym
- IRTD
- Status last verified
- Aug 2019
- First submitted
- 10 Jun 2011
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30273531Vazquez 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.
PubMed 25510385Angriman 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.
PubMed 25424529Ferreyro 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.
PubMed 23875619
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institutional Registry of Thromboembolic Disease
- ClinicalTrials.gov ID
- NCT01372514
- Acronym / sponsor ID
- IRTD / 995
- Conditions
- Thromboembolism, Venous Thromboembolism, Pulmonary Embolism
- Keywords
- Thromboembolism, Venous Thromboembolism, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Equal to or older than 17 years.
- Followed in HIBA.
- Suspected pulmonary embolism or diagnosed venous thrombosis
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence
Time frame: 4 years
1 secondary outcome
evaluate new hypothesis
Time frame: yearly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 30273531Grande 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.
- Derived from this study: PubMed 25510385Vazquez 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.
- Derived from this study: PubMed 25424529Angriman 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.
- Derived from this study: PubMed 23875619Ferreyro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lourdes M Posadas-Martínez, MD contact
Diego H Giunta, MD principal investigator
Internal Medicine Clinical research Area Coordinator
Fernan Gonzales Bernaldo de Quirós, MD study director
Internal Medicine Clinical Research Area Chief
Fernando Vazquez, MD study chair
Internal Medicine Staff
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism and Venous Thromboembolism, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego H Giunta, MD (005411-49590200 ext. 4419, diego.giunta@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01372514, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.