Compression stockings to prevent post-thrombotic syndrome: the SOX trial
ISRCTN | ISRCTN71334751 |
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DOI | https://doi.org/10.1186/ISRCTN71334751 |
ClinicalTrials.gov number | NCT00143598 |
Secondary identifying numbers | MCT-63142 |
- Submission date
- 01/09/2005
- Registration date
- 01/09/2005
- Last edited
- 10/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Center for Clinical Epidemiology and Community Studies
SMBD Jewish General Hospital
3755 Cote Ste. Catherine Rm A-127
Montreal, Quebec
H3T 1E2
Canada
Phone | +1 (0)514 3408222 (4667) |
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susan.kahn@mcgill.ca |
Public
SMBD Jewish General Hospital
3755 Cote Ste. Catherine Rm A-127
Montreal, Quebec
H3T 1E2
Canada
Phone | +1 (0)514 340 8222 ext. 4667 |
---|---|
susan.kahn@mcgill.ca |
Study information
Study design | Multicentre two-arm placebo randomised parallel device trial with study participant, study investigator, and outcome assessor blinded. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | Compression stockings to prevent post-thrombotic syndrome: a multicentre, two arm, placebo-controlled randomised parallel device trial |
Study acronym | SOX |
Study objectives | To determine whether Elastic Compression Stockings (ECS) used for two years are effective in preventing the Post-Thrombotic Syndrome (PTS) in patients with symptomatic proximal Deep Venous Thrombosis (DVT). Previous hypothesis: To determine whether Elastic Compression Stockings (ECS) used for two years, and celecoxib, a COX-II inhibitor, used for 30 days are effective in preventing the Post-Thrombotic Syndrome (PTS) in patients with symptomatic proximal Deep Venous Thrombosis (DVT). Sub -study registered with ClinicalTrials.gov: NCT01615705 - Biomarker Sub Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX) Trial (Bio-SOX) Sub -study registered with ClinicalTrials.gov: NCT01615692 - The 36-month Extension to Follow up Sub Study |
Ethics approval(s) | 1. Canada: The Research Ethics Committee of Sir Mortimer B Davis Jewish General Hospital, 30/07/2003. This ethics approval was amended on 27/01/2005 to take into account the removal of the celecoxib intervention and consequent protocol changes. 2. USA: The University of Oklahoma Health Sciences Center Institutional Review Board (USA), 31/07/2007, ref: 13513. All other centres subsequent to this in the USA will require full ethics approval before recruiting participants. |
Health condition(s) or problem(s) studied | Deep vein thrombosis |
Intervention | 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 removed upon retiring, beginning within a week (as soon as possible) after DVT diagnosis, and continued for two years 2. Control interventions: knee-length, inactive (i.e. no compression) stocking, identical in appearance to active ECS, worn on the DVT-affected leg daily, applied upon waking and removed upon retiring, beginning within a week (as soon as possible) after DVT diagnosis, and continued for two years Previous interventions: 1. Experimental interventions: 1.1. Knee-length, 30 - 40 mmHg (Class II), graduated ECS worn on the DVT-affected leg daily, applied upon waking and removed upon retiring, beginning within a week (as soon as possible) after DVT diagnosis, and continued for two years 1.2. Celecoxib, 200 mg orally (po) twice a day (BID), begun on the day of DVT diagnosis and continued for 30 days 2. Control interventions: 2.1. Knee-length, inactive (i.e. no compression) stocking, identical in appearance to active ECS, worn on the DVT-affected leg daily, applied upon waking and removed upon retiring, beginning within a week (as soon as possible) after DVT diagnosis, and continued for two years 2.2. Placebo, identical in appearance to celecoxib, one tablet po BID, begun on the day of DVT diagnosis and continued for 30 days |
Intervention type | Other |
Primary outcome measure | Incidence of post-thrombotic syndrome (PTS) at two years |
Secondary outcome measures | 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 |
Overall study start date | 01/04/2003 |
Completion date | 31/01/2012 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 800 |
Key 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. |
Key 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 |
Date of first enrolment | 01/04/2003 |
Date of final enrolment | 17/02/2010 |
Locations
Countries of recruitment
- Canada
- United States of America
Study participating centre
H3T 1E2
Canada
Sponsor information
Not defined
3755 Côte Ste-Catherine Road
Montreal, Quebec
H3T 1E2
Canada
Phone | +1 (0)514 340 8222 |
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wainberg@ldi.jgh.mcgill.ca | |
https://ror.org/056jjra10 |
Funders
Funder type
Industry
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Basic results | No | No | |||
Protocol article | protocol | 24/07/2007 | Yes | No | |
Results article | results | 08/03/2014 | Yes | No | |
Results article | results | 01/12/2014 | Yes | No |
Editorial Notes
Please note that in 2005, the intervention using Celecoxib was removed from this trial due to reports of negative effects in a large colorectal cancer prevention clinical trial. Thus, the SOX Trial protocol was amended to take this into account. The most recent changes to the protocol were made to this trial record on the 10/06/2009.
Due to the removal of the Celecoxib intervention, the recruitment resumed in February 2005, and the overall trial end date has now been extended by one year to 30/12/2011 (amended 10/06/2009). The previous overall trial end date was 30/03/2008 (amended 13/05/2008).
As of 17/02/2010 this record has been updated to include an extended overall trial end date; the initial overall trial end date of this record was 30/12/2011. Please note that enrolment to this trial is now completed.