ThrombosisNCT01595763
Diagnostic Approach of Deep Vein Thrombosis in Primary Care
An observational study of Thrombosis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
To asses the cost-effectiveness of implementing different diagnostic strategies in patients with clinical assessment of suspected deep vein thrombosis (DVT) at first presentation in primary care. To evaluate the utility of using D dimer test to diagnose DVT in primary care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- What is being tested?
- D Dimer and ultrasonography
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2011to not given
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of Hospital Santa Creu i Sant Pau
Who may be able to join
- Patients referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of Hospital Santa Creu i Sant Pau
Who cannot join
- anticoagulant treatment
- patients who will not be able to follow control visit
- patients with oncologic treatment
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Sergi Bellmunt, MD, 935537634, sbellmunt@santpau.cat
Eva Fuentes Camps
About this study
Official title: Orientación Diagnóstica de la Trombosis Venosa Profunda en la Atención Primaria. Estudio de Coste Efectividad
To asses the cost-effectiveness of implementing different diagnostic strategies in patients with clinical assessment of suspected deep vein thrombosis (DVT) at first presentation in primary care. To evaluate the utility of using D dimer test to diagnose DVT in primary care. To describe the differential diagnosis and the strength of association between each outcome variable and the clinical prediction guide and the final diagnosis. It is a cross-sectional, multicentric study.
Read the detailed description
The participants are the patients referred from the 15 primary care centers (400.000 inhabitants) to the Hospital de la Santa Creu i Sant Pau emergency department with suspected DVT. We will enter physical examination and anamnesis variables, Wells and Oudega's rules variables, D-Dimer value and ultrasonography result. The outcome variables are the cost (€) of each possible way of diagnostic approach and the effectiveness will be measured by the ultrasonography result, which confirms or excludes the diagnosis. The sample will include 437 patients. A decision tree will be developed to analyze the different diagnostic options in DVT cases, using standard notation.
- Conditions
- Thrombosis
- Being tested
- D Dimer and ultrasonography
- Keywords
- Deep vein thrombosis, Primary care, Diagnosis, Clinical model
- Medical subject headings
- Thrombosis, Venous Thrombosis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D Dimer and ultrasonographyOther
clinical history, Dimer D, ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Deep Vein Thromobosis signs or symptoms | Not described Receives: Other: D Dimer and ultrasonography |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595763
- Sponsor's protocol ID
- IIBSP-TVP-2011-13
- Status last verified
- Apr 2011
- First submitted
- 7 May 2012
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orientación Diagnóstica de la Trombosis Venosa Profunda en la Atención Primaria. Estudio de Coste Efectividad
- ClinicalTrials.gov ID
- NCT01595763
- Acronym / sponsor ID
- IIBSP-TVP-2011-13
- Conditions
- Thrombosis
- Keywords
- Deep vein thrombosis, Primary care, Diagnosis, Clinical model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Nov 2011
- First posted
- 10 May 2012 (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.
To asses the cost-effectiveness of implementing different diagnostic strategies in patients with clinical assessment of suspected deep vein thrombosis (DVT) at first presentation in primary care. To evaluate the utility of using D dimer test to diagnose DVT in primary care. To describe the differential diagnosis and the strength of association between each outcome variable and the clinical prediction guide and the final diagnosis. It is a cross-sectional, multicentric study.
Detailed description
The participants are the patients referred from the 15 primary care centers (400.000 inhabitants) to the Hospital de la Santa Creu i Sant Pau emergency department with suspected DVT. We will enter physical examination and anamnesis variables, Wells and Oudega's rules variables, D-Dimer value and ultrasonography result. The outcome variables are the cost (€) of each possible way of diagnostic approach and the effectiveness will be measured by the ultrasonography result, which confirms or excludes the diagnosis. The sample will include 437 patients. A decision tree will be developed to analyze the different diagnostic options in DVT cases, using standard notation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Vein Thromobosis signs or symptoms | – | Other: D Dimer and ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of Hospital Santa Creu i Sant Pau
Key inclusion criteria (1 listed)
- Patients referred by physicians with clinical suspicions of a first episode of deep vein thrombosis visited in emergency department of Hospital Santa Creu i Sant Pau
Key exclusion criteria (3 listed)
- anticoagulant treatment
- patients who will not be able to follow control visit
- patients with oncologic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| D Dimer and ultrasonographyclinical history, Dimer D, ultrasonography | Other | Deep Vein Thromobosis signs or symptoms |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2012.
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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.
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 Thrombosis, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 inclusion and 3 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 10 May 2012. 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 Spain. 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 Eva Fuentes (932082570, 31498efc@comb.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 10 May 2012.