The 36-month Extension to Follow up Sub Study | NCT01615692

Studies
The 36-month Extension to Follow up Sub Study

NCT01615692

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Status

Withdrawn

Last Update Posted

Apr 18, 2018Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Postphlebitic Syndrome
Post-Thrombotic Syndrome
Deep Vein Thrombosis

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
ISRCTN71334751; NCT00143598	Registry Identifier	ISRCTN; Clinicaltrials.gov

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sub study was not pursued as overall trial was negative

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Jun 1, 2012

First Submission Date that Met QC Criteria

Jun 8, 2012

First Posted Date

Jun 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2018

Last Update Posted Date

Apr 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Susan Kahn, SOX Trial Principal Investigator, Sir Mortimer B. Davis - Jewish General HospitalPrincipal Investigator

Lead Sponsor

Sir Mortimer B. Davis - Jewish General HospitalOTHER

Collaborators

Name	Class
Canadian Institutes of Health Research (CIHR)	OTHER_GOV
Heart and Stroke Foundation of Canada	OTHER
Sigvaris Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Measure	Description	Time Frame
Incidence of PTS and PTS severity		3 year follow up

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Susan R. Kahn, M.D., M.Sc.	Sir Mortimer B. Davis - Jewish General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Victoria Heart Institute Foundation		Victoria	British Columbia	V8R 4R2	Canada
St. Boniface General Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17711595	Background	Kahn SR, Shbaklo H, Shapiro S, Wells PS, Kovacs MJ, Rodger MA, Anderson DR, Ginsberg JS, Johri M, Tagalakis V; SOX Trial Investigators. Effectiveness of compression stockings to prevent the post-thrombotic syndrome (the SOX Trial and Bio-SOX biomarker substudy): a randomized controlled trial. BMC Cardiovasc Disord. 2007 Jul 24;7:21. doi: 10.1186/1471-2261-7-21.

ID	Term
D011186	Postphlebitic Syndrome
D054070	Postthrombotic Syndrome
D020246	Venous Thrombosis

ID	Term
D010689	Phlebitis
D016491	Peripheral Vascular Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases