Compression stockings to prevent post-thrombotic syndrome: the SOX trial

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 800

Inclusion Criteria

Current inclusion criteria (protocol updated in August 2008):
Consecutive patients aged greater than or equal to 18 years old, either sex, with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or Pulmonary Embolism [PE]) who have no contraindications to standard treatment with heparin and/or warfarin, and who provide informed consent to participate.

Previous inclusion criteria (January 2005):
Consecutive patients aged greater than or equal to 18 years old, either sex, with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 10 days (with or without concurrent distal DVT or Pulmonary Embolism [PE]) who have no contraindications to standard treatment with heparin and/or warfarin, and who provide informed consent to participate.

Initial inclusion criteria (January 2004):
Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 72 hours (with or without concurrent distal DVT or Pulmonary Embolism [PE]) who have no contraindications to standard treatment with heparin and/or warfarin, and who provide informed consent to participate.

Exclusion Criteria

Current exclusion criteria (protocol updated in January 2005):
1. Contraindication to compression stockings
2. Limited lifespan (estimated less than six months)
3. Geographic inaccessibility preventing return for follow-up visits
4. Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
5. Treatment of acute DVT with thrombolytic agents

Previous exclusion criteria:
1. Contraindication to compression stockings
2. Contraindication to celecoxib
3. History of warfarin, aspirin or Non-Steroidal Anti-Inflammatory Drug (NSAID)-associated major haemorrhagic event
4. Regular, daily use of NSAIDs
5. Inability/unwillingness to stop anti-platelet drugs for 30 days
6. Limited lifespan (estimated less than six months)
7. Geographic inaccessibility preventing return for follow-up visits
8. Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily
9. Treatment of acute DVT with thrombolytic agents

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of post-thrombotic syndrome (PTS) at two years

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures (protocol updated in January 2005):<br>1. Severity of PTS at two years follow up, including incidence of venous ulcer<br>2. Incidence of objectively confirmed recurrent VTE, and death from VTE, over two years<br>3. C-reactive protein at 30 days compared to baseline value<br>4. Quality of life over the two-year follow up<br>5. Cost-effectiveness<br><br>Previous secondary outcome measures:<br>1. Severity of PTS at two years follow up, including incidence of venous ulcer<br>2. Incidence of objectively confirmed recurrent VTE, and death from VTE, over two years<br>3. Incidence of major bleeding or arterial thrombotic events during the first 60 days<br>4. C-reactive protein at 30 days compared to baseline value<br>5. Quality of life over the two-year follow up<br>6. Cost-effectiveness