Deep Venous ThrombosisPhase 3PALLADIONCT01412242
Simplification of the Diagnosis of Deep Vein Thrombosis
A Phase 3 study testing Extensive search for isolated calf DVT in people with Deep Venous Thrombosis, run by University of Padova at 1 site in Italy.
Trial summary
Prospective cohort study aimed at simplifying the diagnostic approach to symptomatic patients with the clinical suspicion of deep vein thrombosis (DVT) of the lower extremities. All patients will receive a pre-test clinical probability (PTP) and the determination of D-dimer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- Extensive search for isolated calf DVT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2011to Sep 2014
- Phase
- Phase 3
- 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
Who may be able to join
- outpatients with clinically suspected DVT
- signed informed consent
Who cannot join
- concomitant signs or symptoms of pulmonary embolism
- previous DVT of the affected leg
- referral for superficial vein thrombosis or bilateral DVT
- ongoing or planned anticoagulant therapy
- need for pharmacological thromboprophylaxis (e.g. recent surgery or medical disease)
- inpatient status
Show all 9Show fewer
- unavailability to follow up
- pregnancy
- age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Optimal Approach to the Ultrasound Diagnosis of Deep Vein Thrombosis of the Lower Extremities in Symptomatic Patients
Prospective cohort study aimed at simplifying the diagnostic approach to symptomatic patients with the clinical suspicion of deep vein thrombosis (DVT) of the lower extremities. All patients will receive a pre-test clinical probability (PTP) and the determination of D-dimer. Patients with low PTP and negative D-dimer will have the diagnosis ruled out. All other patients will undergo compression ultrasonography (CUS) of the proximal vein system. Patients with negative CUS and either low PTP or negative D-dimer will have the diagnosis ruled out, while those with high PTP and positive D-dimer will undergo extensive ultrasound investigation of the calf vein system. All patients in whom the diagnosis of DVT is ruled out will be followed-up prospectively up to three months for documenting the development of symptomatic thromboembolic events.
Read the detailed description
All eligible patients will undergo D-dimer measurement and a formal assessment of pre-test clinical probability (PTP) by means of the Wells score. Patients with unlikely PTP and negative D-dimer will have DVT ruled out and will undergo a 3-month clinical follow-up. If at least one of the two tests is positive, patients will undergo CUS of the proximal vein system by investigating at least the common femoral vein at the groin, the superficial femoral vein at the mid thigh and the popliteal vein(s) in the popliteal fossa. A positive CUS will adjudicate proximal DVT. In the case of negative CUS of the proximal vein system, patients with either negative D-dimer or unlikely PTP will have DVT ruled out, and will undergo a 3-month follow up. Only patients with concomitant likely PTP and positive D-dimer will undergo whole-leg ultrasonography with interrogation of the calf veins. A positive test will adjudicate distal DVT. Patients with negative test will undergo a 3-month clinical follow up.
Follow-up. All patients in whom DVT is ruled out will be monitored for 3 months (either by clinical visit or by telephone contact) after the enrolment in the study. Patients with clinical symptoms of DVT or PE during follow-up will undergo objective diagnostic testing (venous ultrasound for suspected DVT and spiral CT-scan or VQ scan for suspected PE). All source documents will be sent out for an independent adjudication. In case of death, PE diagnosis will be adjudicated by means of autopsy, if available. If autopsy is not available, the adjudication of PE-related death will be done based on clinical documentation.
D-dimer. All quantitative D-dimer tests available at each center will be acceptable for the purpose of this study. D-dimer will be considered negative according to the cut-offs provided by manufacturers.
Sample size. The investigators expect that in every 100 symptomatic outpatients DVT will be excluded without the need for objective testing in approximately 30%, while approximately 20% will have a CUS-detected proximal DVT, approximately 15% will have negative CUS and unlikely PTP in spite of positive D-Dimer (no need for further investigation), approximately 15% will have negative CUS and negative D-Dimer in spite of likely PTP (no need for further investigation, and approximately 20% will have negative CUS and both likely PTP and positive D-Dimer (thus requiring interrogation of the calf vein system).
The investigators hypothesize that the incidence of venous thromboembolic events during follow up in patients labeled as not having DVT will not exceed 1% with the application of the proposed algorithm, and that the upper limit of the 95% confidence intervals around this proportion will not exceed 2%. Accordingly, ap proximately 1100 patients should be enroled.
- Conditions
- Deep Venous Thrombosis
- Being tested
- Extensive search for isolated calf DVT
- Keywords
- Deep vein thrombosis, Ultrasonography, Pulmonary embolism, D-dimer, Pre-test probability
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensive search for isolated calf DVTOther
Extensive search for isolated calf DVT in patients with negative CUS of the proximal veins who have a high PTP and a positive D-dimer
| Study group | Role | What they receive |
|---|---|---|
| Extensive search for isolated calf DVT | Experimental | As this is a prospective cohort study, for definition there is only 1 arm Receives: Other: Extensive search for isolated calf DVT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of withdrawing anticoagulation from patients labeled as not having DVT on the basis of a one-day examination
To assess the rate of symptomatic thromboembolic events occurring up to 3 months after DVT exclusion
Measured: Up to 3 months
Secondary outcomes (1)
The rate of isolated calf vein thrombi
Patients with high PTP and positive D-dimer in spite of negative CUS of the proximal vein system will undergo extensive search for isolated calf vein DVT.
Measured: Up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Venous ThrombosisStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Prandoni, University of Padova
- Investigators
- Paolo Prandoni, MD, PhD, Study chair, University of Padua, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412242
- Sponsor's protocol ID
- 2188P
- Acronym
- PALLADIO
- Status last verified
- Jan 2015
- First submitted
- 5 Aug 2011
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ageno W, Camporese G, Riva N, Iotti M, Bucherini E, Righini M, Kamphuisen PW, Verhamme P, Douketis JD, Tonello C, Prandoni P; PALLADIO Study Investigators. Analysis of an algorithm incorporating limited and whole-leg assessment of the deep venous system in symptomatic outpatients with suspected deep-vein thrombosis (PALLADIO): a prospective, multicentre, cohort study. Lancet Haematol. 2015 Nov;2(11):e474-80. doi: 10.1016/S2352-3026(15)00190-8. Epub 2015 Oct 18.
PubMed 26686257
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Optimal Approach to the Ultrasound Diagnosis of Deep Vein Thrombosis of the Lower Extremities in Symptomatic Patients
- ClinicalTrials.gov ID
- NCT01412242
- Acronym / sponsor ID
- PALLADIO / 2188P
- Conditions
- Deep Venous Thrombosis
- Keywords
- Deep vein thrombosis, Ultrasonography, Pulmonary embolism, D-dimer, Pre-test probability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,100 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Aug 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.
Prospective cohort study aimed at simplifying the diagnostic approach to symptomatic patients with the clinical suspicion of deep vein thrombosis (DVT) of the lower extremities. All patients will receive a pre-test clinical probability (PTP) and the determination of D-dimer. Patients with low PTP and negative D-dimer will have the diagnosis ruled out. All other patients will undergo compression ultrasonography (CUS) of the proximal vein system. Patients with negative CUS and either low PTP or negative D-dimer will have the diagnosis ruled out, while those with high PTP and positive D-dimer will undergo extensive ultrasound investigation of the calf vein system. All patients in whom the diagnosis of DVT is ruled out will be followed-up prospectively up to three months for documenting the development of symptomatic thromboembolic events.
Detailed description
All eligible patients will undergo D-dimer measurement and a formal assessment of pre-test clinical probability (PTP) by means of the Wells score. Patients with unlikely PTP and negative D-dimer will have DVT ruled out and will undergo a 3-month clinical follow-up. If at least one of the two tests is positive, patients will undergo CUS of the proximal vein system by investigating at least the common femoral vein at the groin, the superficial femoral vein at the mid thigh and the popliteal vein(s) in the popliteal fossa. A positive CUS will adjudicate proximal DVT. In the case of negative CUS of the proximal vein system, patients with either negative D-dimer or unlikely PTP will have DVT ruled out, and will undergo a 3-month follow up. Only patients with concomitant likely PTP and positive D-dimer will undergo whole-leg ultrasonography with interrogation of the calf veins. A positive test will adjudicate distal DVT. Patients with negative test will undergo a 3-month clinical follow up.
Follow-up. All patients in whom DVT is ruled out will be monitored for 3 months (either by clinical visit or by telephone contact) after the enrolment in the study. Patients with clinical symptoms of DVT or PE during follow-up will undergo objective diagnostic testing (venous ultrasound for suspected DVT and spiral CT-scan or VQ scan for suspected PE). All source documents will be sent out for an independent adjudication. In case of death, PE diagnosis will be adjudicated by means of autopsy, if available. If autopsy is not available, the adjudication of PE-related death will be done based on clinical documentation.
D-dimer. All quantitative D-dimer tests available at each center will be acceptable for the purpose of this study. D-dimer will be considered negative according to the cut-offs provided by manufacturers.
Sample size. The investigators expect that in every 100 symptomatic outpatients DVT will be excluded without the need for objective testing in approximately 30%, while approximately 20% will have a CUS-detected proximal DVT, approximately 15% will have negative CUS and unlikely PTP in spite of positive D-Dimer (no need for further investigation), approximately 15% will have negative CUS and negative D-Dimer in spite of likely PTP (no need for further investigation, and approximately 20% will have negative CUS and both likely PTP and positive D-Dimer (thus requiring interrogation of the calf vein system).
The investigators hypothesize that the incidence of venous thromboembolic events during follow up in patients labeled as not having DVT will not exceed 1% with the application of the proposed algorithm, and that the upper limit of the 95% confidence intervals around this proportion will not exceed 2%. Accordingly, ap proximately 1100 patients should be enroled.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extensive search for isolated calf DVT | Experimental | Other: Extensive search for isolated calf DVTAs this is a prospective cohort study, for definition there is only 1 arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- outpatients with clinically suspected DVT
- signed informed consent
Key exclusion criteria (9 listed)
- concomitant signs or symptoms of pulmonary embolism
- previous DVT of the affected leg
- referral for superficial vein thrombosis or bilateral DVT
- ongoing or planned anticoagulant therapy
- need for pharmacological thromboprophylaxis (e.g. recent surgery or medical disease)
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 |
|---|---|---|
| Extensive search for isolated calf DVTExtensive search for isolated calf DVT in patients with negative CUS of the proximal veins who have a high PTP and a positive D-dimer | Other | Extensive search for isolated calf DVT |
Primary outcome
Safety of withdrawing anticoagulation from patients labeled as not having DVT on the basis of a one-day examination
Time frame: Up to 3 months
To assess the rate of symptomatic thromboembolic events occurring up to 3 months after DVT exclusion
1 secondary outcome
The rate of isolated calf vein thrombi
Time frame: Up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Derived from this study: PubMed 26686257Ageno W, Camporese G, Riva N, Iotti M, Bucherini E, Righini M, Kamphuisen PW, Verhamme P, Douketis JD, Tonello C, Prandoni P; PALLADIO Study Investigators. Analysis of an algorithm incorporating limited and whole-leg assessment of the deep venous system in symptomatic outpatients with suspected deep-vein thrombosis (PALLADIO): a prospective, multicentre, cohort study. Lancet Haematol. 2015 Nov;2(11):e474-80. doi: 10.1016/S2352-3026(15)00190-8. Epub 2015 Oct 18.
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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.
Paolo Prandoni, MD, PhD study chair
University of Padua, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Extensive search for isolated calf DVT in people with Deep Venous Thrombosis, run by University of Padova at 1 site in Italy.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 26 Jan 2015. 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 Italy. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of withdrawing anticoagulation from patients labeled as not having DVT on the basis of a one-day examination (time frame: Up to 3 months). 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 NCT01412242, which also lists 1 linked publication.
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 26 Jan 2015.