Deep vein thrombosis Circulatory System Deep vein thrombosis (DVT)
Conditions
Interventions
Current interventions (protocol updated in January 2005):
1. Experimental interventions: knee-length, 30 - 40 mmHg (Class II), graduated ECS worn on the DVT-affected leg daily, applied upon waking and
Sponsors
Sir Mortimer B. Davis Jewish General Hospital-Mtl (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of post-thrombotic syndrome (PTS) at two years | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures (protocol updated in January 2005): 1. Severity of PTS at two years follow up, including incidence of venous ulcer 2. Incidence of objectively confirmed recurrent VTE, and death from VTE, over two years 3. C-reactive protein at 30 days compared to baseline value 4. Quality of life over the two-year follow up 5. Cost-effectiveness Previous secondary outcome measures: 1. Severity of PTS at two years follow up, including incidence of venous ulcer 2. Incidence of objectively confirmed recurrent VTE, and death from VTE, over two years 3. Incidence of major bleeding or arterial thrombotic events during the first 60 days 4. C-reactive protein at 30 days compared to baseline value 5. Quality of life over the two-year follow up 6. Cost-effectiveness | — |
Countries
Canada, United States of America
Contacts
Public ContactSusan Kahn
Outcome results
None listed