Simplification of the Diagnosis of Deep Vein Thrombosis

NCT01412242 | Completed Phase 3 DMC

• 1 other identifier: 2188P
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Deep Venous Thrombosis

Keywords

Deep vein thrombosis; Ultrasonography; Pulmonary embolism; D-dimer; Pre-test probability

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 3 months

Secondary Outcomes (1)

• The rate of isolated calf vein thrombi

  Up to 1 day

Study Arms (1)

Extensive search for isolated calf DVT

EXPERIMENTAL

As this is a prospective cohort study, for definition there is only 1 arm

Other: Extensive search for isolated calf DVT

Interventions

Extensive search for isolated calf DVT OTHER

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

Extensive search for isolated calf DVT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• outpatients with clinically suspected DVT
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Paolo Prandoni

Padua, 35128, Italy

Location

Related Publications (1)

• 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.

  PMID: 26686257 DERIVED

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Paolo Prandoni, MD, PhD

  University of Padua, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 9, 2011
• Study Start: March 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

IT (1)