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| Name | Class |
|---|---|
| BioMérieux | INDUSTRY |
| Centre Hospitalier Régional et Universitaire de Brest | OTHER |
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The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment.
Up to 50% of patients with a first episode of venous thromboembolism (VTE) have no identifiable cause (i.e. are unprovoked VTEs). The risk of recurrent VTE in this large group of patients with unprovoked VTE after 3-6 months of anticoagulant therapy is 5-10.8% in the year following discontinuation of oral anticoagulant therapy. One in six to one in twenty recurrences of a new VTE are fatal. Given the intermediate risks of recurrence in unselected unprovoked VTE patients, clinicians do not have clear guidance on whether to continue or discontinue anticoagulants in patients with unprovoked VTE. Recently attention has turned to the concept of risk stratification to identify subgroups of patients with unprovoked VTE who could safely discontinue oral anticoagulation therapy (OAT).
In the REVERSE I study, a clinical decision rule derivation study conducted from 2001 to 2006, we developed and internally validated the clinical decision rule "Men continue and HER DOO2" that identifies patients with a first unprovoked VTE who likely have a low risk of recurrent VTE and could safely discontinue OAT subsequent to 5-7 months of OAT. The present study will evaluate if the "Men continue and HER DOO2" rule (comprised of gender, elevated D-dimer levels, post-thrombotic signs, obesity, and older age) is safe, clinically useful, and reproducible when prospectively implemented in multiple centers and a variety of settings. If this clinical decision rule is validated, it will provide physicians with important information to allow them to more confidently identify unprovoked VTE patients at low risk of VTE recurrence who may not need to continue OAT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Discontinue OAT or AAA | Experimental | Patients classified as being at low risk of recurrent VTE by the "HER DOO2"rule. If the clinical decision rule indicates that a patient is at low recurrence risk (<3% per year); anticoagulant therapy will be withdrawn and the participant will then be followed for 1 year for any VTE recurrence and/or bleeding. |
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| 2 Observation arm | No Intervention | Men and patients classified as being at high risk of recurrent VTE by the "HER DOO2"rule. If the clinical decision rule indicates that a patient is at high recurrence risk then the decision to continue or discontinue anticoagulant therapy will be left to the discretion of physicians and patients as per current standard of care and this decision recorded. High risk patients (females classified as being at high risk of recurrent VTE by the CDR, and all males) will then be followed as an observational cohort for 1 year for any VTE recurrence and/or bleeding. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of the"Men continue and HER DOO2" rule | Other | Consecutive patients will have the"Men continue and HER DOO2" rule applied by the attending physician between 5 - 12 months after treatment for a first unprovoked objectively proven major VTE. "Men continue and HER DOO2" rule: all men continue oral anticoagulants and women with 2 or more of the following features after 5-7 months of OAT should continue oral anticoagulants:1) HER - any Hyperpigmentation, Edema and Redness of either lower extremity, 2) Vidas D-dimer ≥250ug/L, 3) Obesity - BMI ≥30 kg/m2 and 4) Older age - Age ≥65 years. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary study outcome is the incidence of adjudicated recurrent major VTE at 1 year in patients deemed by the "Men and HER DOO2" CDR to be at low risk of recurrent VTE. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Any VTE 1 year event rate in low risk patients | One year | |
| Major bleeding 1 year event rate in un-anticoagulated low risk patients | One year | |
| Major VTE 1 year event rate in high risk patients who continue anticoagulant therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Rodger, MD, MSc | Ottawa Hospital Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis | Santa Monica | California | United States | |||
| Penobscot Bay Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18725614 | Background | Rodger MA, Kahn SR, Wells PS, Anderson DA, Chagnon I, Le Gal G, Solymoss S, Crowther M, Perrier A, White R, Vickars L, Ramsay T, Betancourt MT, Kovacs MJ. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ. 2008 Aug 26;179(5):417-26. doi: 10.1503/cmaj.080493. | |
| 28314711 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 26, 2017 | |
| Reset | Aug 3, 2017 |
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|
|
| One year |
| Major VTE 1 year event rate in high risk patients who discontinue anticoagulant therapy | One year |
| Major Bleeding 1 year event rate in high risk patients | One year |
| Clinical utility of the rule | One year |
| Inter-observer reliability of the clinical decision rule | One year |
| Rockport |
| Maine |
| United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| Prince of Wales Hospital | Sydney | New South Wales | Australia |
| CUB Hopital Erasme | Brussels | Belgium |
| CDHA-Queen Elizabeth II Health Science Centre | Halifax | Nova Scotia | B3H2Y9 | Canada |
| Hamilton Health Sciences Center | Hamilton | Ontario | Canada |
| Hamilton Health Sciences Corporation | Hamilton | Ontario | Canada |
| Victoria Hospital | London | Ontario | N6A 4G5 | Canada |
| Ottawa Health Research Institute | Ottawa | Ontario | K1Y 4E9 | Canada |
| University Health Network | Toronto | Ontario | Canada |
| SMBD Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Hopital Sacre Coeur | Montreal | Quebec | Canada |
| McGill University Health Centre | Montreal | Quebec | Canada |
| St. Mary's Hospital - CHUM | Montreal | Quebec | Canada |
| Hopital Enfant Jesus | Québec | Quebec | Canada |
| Saskatchewan Drug Research Institute | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Centre Hospitalier Regional Universitaire de Brest | Brest | France |
| Orange Lifesciences | Nirmaya | India |
| Sahyadri Speciality Hospital | Pune | India |
| Shefali Centre | Shefali | India |
| Jashvant Patel Clinic | Surat | India |
| Hopitaux Universitaires de Geneve | Geneva | Switzerland |
| Rodger MA, Le Gal G, Anderson DR, Schmidt J, Pernod G, Kahn SR, Righini M, Mismetti P, Kearon C, Meyer G, Elias A, Ramsay T, Ortel TL, Huisman MV, Kovacs MJ; REVERSE II Study Investigators. Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: multinational prospective cohort management study. BMJ. 2017 Mar 17;356:j1065. doi: 10.1136/bmj.j1065. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 26, 2017 | Aug 3, 2017 |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000081415 | Clinical Decision Rules |
| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| D008919 | Investigative Techniques |
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