Simplification of the Diagnosis of Deep Vein Thrombosis (PALLADIO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2011 by University of Padova
Sponsor:
Information provided by:
University of Padova
ClinicalTrials.gov Identifier:
NCT01412242
First received: August 5, 2011
Last updated: June 27, 2013
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Deep Venous Thrombosis
Other: Extensive search for isolated calf DVT
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Identification of the Optimal Approach to the Ultrasound Diagnosis of Deep Vein Thrombosis of the Lower Extremities in Symptomatic Patients

Resource links provided by NLM:


Further study details as provided by University of Padova:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    To assess the rate of symptomatic thromboembolic events occurring up to 3 months after DVT exclusion


Secondary Outcome Measures:
  • The rate of isolated calf vein thrombi [ Time Frame: Up to 1 day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1100
Study Start Date: March 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Extensive search for isolated calf DVT
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • outpatients with clinically suspected DVT
  • signed informed consent

Exclusion Criteria:

  • 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
  • unavailability to follow up
  • pregnancy
  • age < 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412242

Contacts
Contact: Paolo Prandoni, MD, PhD +39 049 8212656 paoloprandoni@tin.it
Contact: Paolo Prandoni, MD,PhD +39 049 8212656 paoloprandoni@tin.it

Locations
Italy
Paolo Prandoni Recruiting
Padua, Italy, 35128
Contact: Paolo Prandoni, MD, PhD    +39 049 8212656    paoloprandoni@tin.it   
Contact: Paolo Prandoni, MD,PhD    +39 049 8212656    paoloprandoni@tin.it   
Principal Investigator: Giuseppe Andreozzi, MD         
Sponsors and Collaborators
University of Padova
Investigators
Study Chair: Paolo Prandoni, MD, PhD University of Padua (Italy)
  More Information

No publications provided

Responsible Party: Paolo Prandoni, Department of Cardiothoracic and Vascular Sciences, University of Padua
ClinicalTrials.gov Identifier: NCT01412242     History of Changes
Other Study ID Numbers: 2188P
Study First Received: August 5, 2011
Last Updated: June 27, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Padova:
Deep vein thrombosis
Ultrasonography
Pulmonary embolism
D-dimer
Pre-test probability

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on October 16, 2014