NCT00426075

Brief Summary

Prospective controlled randomized clinical trial. Consecutive patients with acute proximal deep vein thrombosis of the lower extremities, with or without contemporary manifestations of pulmonary embolism, are randomized to receive either a below-knee or a full-leg graduated compression (30-40 mm Hg at the ankle) elastic stocking for prevention of the post-thrombotic syndrome (PTS). All patients are followed up to three years to assess the development of the PTS, defined according to a validated clinical score (the Villalta scale). The rate of PTS is compared between the two study groups. In addition, there is an assessment of patients' compliance and tolerability of the two different devices.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

June 10, 2008

Status Verified

June 1, 2008

Enrollment Period

1.8 years

First QC Date

January 23, 2007

Last Update Submit

June 9, 2008

Conditions

Deep Vein Thrombosis

Keywords

Deep vein thrombosis of the lower extremities

Interventions

Elastic stockingsDEVICE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First episode of proximal deep vein thrombosis, as shown by compression ultrasound

You may not qualify if:

  • Previous ipsilateral deep vein thrombosis
  • Preexisting chronic venous insufficiency
  • Bilateral deep vein thrombosis
  • Life expectancy lower than 1 year
  • Severe arteriopathy of the lower limbs
  • Known allergy to elastic stockings
  • Lack of written informed consensus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical and Surgical Sciences, 2nd Chair of Internal Medicine, University of Padua

Padua, Padua, 35128, Italy

Location

Related Publications (1)

  • Prandoni P, Noventa F, Quintavalla R, Bova C, Cosmi B, Siragusa S, Bucherini E, Astorri F, Cuppini S, Dalla Valle F, Lensing AW, Prins MH, Villalta S; Canano Investigators. Thigh-length versus below-knee compression elastic stockings for prevention of the postthrombotic syndrome in patients with proximal-venous thrombosis: a randomized trial. Blood. 2012 Feb 9;119(6):1561-5. doi: 10.1182/blood-2011-11-391961. Epub 2011 Dec 16.

    PMID: 22180438DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Stockings, Compression

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Compression BandagesBandagesEquipment and Supplies

Study Officials

  • Paolo Prandoni, MD, PhD

    Department of Medical and Surgical Sciences, University of Padua, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 24, 2007

Study Start

January 1, 2006

Primary Completion

November 1, 2007

Last Updated

June 10, 2008

Record last verified: 2008-06

Locations

IT(1)