Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN71334751 | Registry Identifier | ISRCTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Heart and Stroke Foundation of Canada | OTHER |
| Sigvaris Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate whether biomarkers of inflammation, genetic thrombophilia and coagulation activation influence Post-Thrombotic Syndrome development in patients with symptomatic proximal deep venous thrombosis.
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. Poor understanding of the pathophysiology and predictors of PTS has hampered progress in its prevention and treatment. Biomarkers reflective of inflammation, genetic thrombophilia and coagulation activation may be of value in predicting PTS development in patients with DVT; they may also provide insight into understanding the underlying mechanisms of PTS, which could result in the development and testing of novel therapies to prevent and treat PTS.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Draw | SOX Subjects: The cohort consists of original subjects from the SOX Trial who consented to participate in the sub study. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Markers of Inflammation | Blood samples drawn at baseline, 1 and 6-mths to evaluate the relationship between CRP, ICAM, IL-6, IL-10 with the subsequent development of PTS. | Baseline |
| Markers of Inflammation | Blood samples drawn at baseline, 1 and 6-mths to evaluate the relationship between CRP, ICAM, IL-6, IL-10 with the subsequent development of PTS. | 1-mth follow up |
| Markers of Other Thrombophilia | Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS. | 6-mth follow up |
| Markers of Inflammation | Blood samples drawn at baseline, 1 and 6-mths to evaluate the relationship between CRP, ICAM, IL-6, IL-10 with the subsequent development of PTS. | 6-month follow up |
| Markers of Other Thrombophilia | Blood samples drawn at 6-mths to evaluate the relationship between D-Dimer, VIII, Lupus anticoagulant, IgG, IgM with the subsequent development of PTS. | 6-month follow up |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Subjects previously enrolled in the SOX Trial (ClinicalTrials.gov Identifier NCT00143598)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan R Kahn, M.D., M.Sc. | Sir Mortimer B. Davis - Jewish General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States | ||
| Duke University Medical Center |
| 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. | |
| 26992609 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples collected and processed by centrifuge to obtain serum, peripheral blood leukocytes and platelet-poor plasma. Samples then aliquoted into 2.0ml microcentrifuge tubes for storage at -80°C until further analysis.
| Durham |
| North Carolina |
| 27710 |
| United States |
| Oklahoma University Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Victoria Heart Institute Foundation | Victoria | British Columbia | V8R 4R2 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| QE II Health Sciences Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Hamilton Health Sciences - General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| Hamilton Health Sciences - Chedoke Division | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hamilton Health Sciences - McMaster University Medical Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 3Z5 | Canada |
| Hamilton Health Sciences - Henderson General Hospital | Hamilton | Ontario | L8V 1C3 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4G5 | Canada |
| The Ottawa Hospital, Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| Sunnybrook & Women's College Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network - Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Centre Hospitalier Pierre-Boucher | Longueuil | Quebec | J4M 2A5 | Canada |
| Hôpital Maisonneuve-Rosemont | Montreal | Quebec | H1T 4M1 | Canada |
| Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame | Montreal | Quebec | H2L 4M1 | Canada |
| Montreal General Hospital - McGill University Health Centre | Montreal | Quebec | H3G 1A4 | Canada |
| Sir Mortimer B. Davis -Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| St. Mary's Hospital Center | Montreal | Quebec | H3T 1M5 | Canada |
| Hôpital du Sacré-Coeur de Montréal | Montreal | Quebec | H4J 1C5 | Canada |
| Centre Hospitalier de l'Université de Montréal - Hôpital Hôtel-Dieu | Montreal | Quebec | Canada |
| Royal Victoria Hospital - McGill University Health Centre | Montreal | Quebec | Canada |
| Centre hospitalier affilié universitaire de Québec, Hôpital de l'Enfant-Jésus | Québec | Quebec | G1J 1Z4 | Canada |
| Rabinovich A, Cohen JM, Cushman M, Kahn SR; BioSOX Investigators. Association between inflammation biomarkers, anatomic extent of deep venous thrombosis, and venous symptoms after deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2015 Oct;3(4):347-353.e1. doi: 10.1016/j.jvsv.2015.04.005. Epub 2015 Aug 1. |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D011186 | Postphlebitic Syndrome |
| D054070 | Postthrombotic Syndrome |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010689 | Phlebitis |
| D016491 | Peripheral Vascular Diseases |
| D014689 | Venous Insufficiency |
Not provided
Not provided