The 36-month Extension to Follow up Sub Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Sigvaris Corporation
Information provided by (Responsible Party):
Dr. Susan Kahn, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01615692
First received: June 1, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to evaluate leg health for one additional year in patients with symptomatic proximal deep venous thrombosis who did not already develop Post-Thrombotic Syndrome (PTS) during the 2 years of follow up in the SOX Trial.


Condition
Postphlebitic Syndrome
Post-Thrombotic Syndrome
Deep Vein Thrombosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Extension to Follow up Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX Trial)

Resource links provided by NLM:


Further study details as provided by Sir Mortimer B. Davis - Jewish General Hospital:

Primary Outcome Measures:
  • Incidence of PTS and PTS severity [ Time Frame: 3 year follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: June 2004
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
36-mth follow up visit
The cohort will consist of original subjects of the SOX Trial who consent to participate in the extension to follow up sub study.

Detailed Description:

The post-thrombotic syndrome (PTS) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (DVT). Affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. At present, there is little to offer for the treatment of this condition. Prevention of PTS is the key to reducing its burden on patients and society. Elastic compression stockings (ECS) for two years following DVT could be helpful in preventing or delaying onset of PTS at three years, however data supporting this is limited.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects previously enrolled in the SOX Trial (ClinicalTrials.gov Identifier NCT00143598) who did not develop PTS by 2 years follow up.

Criteria

Inclusion Criteria:

  • Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism)
  • Who have no contraindications to standard treatment with heparin and/or warfarin, and
  • Who provide informed consent to participate

Exclusion Criteria:

  • Contraindication to compression stockings
  • Limited lifespan (estimated < 6 months)
  • Geographic inaccessibility preventing return for follow-up visits
  • Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
  • Treatment of acute DVT with thrombolytic agents
  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: NCT01615692

Locations
Canada, British Columbia
Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R 4R2
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Hamilton Health Sciences - Chedoke Division
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences - McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences - Henderson General Hospital
Hamilton, Ontario, Canada, L8V 1C3
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Sciences - General Hospital
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Hôpital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Montreal General Hospital - McGill University Health Centre
Montreal, Quebec, Canada, H3G 1A4
St. Mary's Hospital Centre
Montreal, Quebec, Canada, H3T 1M5
Centre Hospitalier de l'Université de Montréal - Hôpital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Royal Victoria Hospital - McGill University Health Centre
Montreal, Quebec, Canada, H3A 1A1
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada, H4J 1C5
Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus
Quebec City, Quebec, Canada, G1J 1Z4
Sponsors and Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Sigvaris Corporation
Investigators
Principal Investigator: Susan R. Kahn, M.D., M.Sc. Sir Mortimer B. Davis - Jewish General Hospital
  More Information

Publications:
Responsible Party: Dr. Susan Kahn, SOX Trial Principal Investigator, Sir Mortimer B. Davis - Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01615692     History of Changes
Other Study ID Numbers: MOP-102610, ISRCTN71334751; NCT00143598
Study First Received: June 1, 2012
Last Updated: April 14, 2014
Health Authority: Canada: Dr. Susan R. Kahn, M.D., M.Sc, Sir Mortimer B. Davis - Jewish General Hospital

Keywords provided by Sir Mortimer B. Davis - Jewish General Hospital:
Elastic Stockings
Stockings, Compression
Randomized Controlled Trials
Quality of Life

Additional relevant MeSH terms:
Postphlebitic Syndrome
Postthrombotic Syndrome
Thrombosis
Venous Thrombosis
Phlebitis
Peripheral Vascular Diseases
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Embolism and Thrombosis

ClinicalTrials.gov processed this record on July 31, 2014