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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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The protocol is a large registry to describe acute, sub-acute and extended duration of anticoagulation management, clinical and economic duration of anticoagulation management, clinical and economic outcomes in patients with treated acute VTE (DVT and PE) in the real-world setting.
Main objectives are to clarify the:
Other objectives are to clarify the additional outcomes of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective cohort 1 | In order to observe temporal trends in management of VTE a first cohort of 5000 consecutive unselected patients treated for acute VTE will be recruited. This cohort will take approximately 9 months to recruit. Potential patients must be assessed for eligibility within 30 days of their acute VTE diagnosis. They will be followed prospectively for 36 months. | ||
| Prospective cohort 2 | In order to observe temporal trends in management of VTE a second cohort of 5000 consecutive unselected patients treated for acute VTE will be recruited. Recruitment into the second cohort will commence when recruitment is completed in the first cohort. This cohort will take approximately 9 months to recruit. Potential patients must be assessed for eligibility within 30 days of their acute VTE diagnosis. They will be followed prospectively for 36 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE) | Rate of recurrent symptomatic VTE (DVT and fatal or non-fatal PE) | 36 months |
| Bleeding events | Frequency, location, severity (classified as major or non-major) | 36 months |
| Hospitalization | Measured by number of occurrences. | 36 months |
| Post Thrombotic Syndrome | Measured by number of occurrences and severity. | 36 months |
| Chronic thromboembolic pulmonary hypertension | Measured by number of occurrences and severity. | 36 months |
| IVC filter placement | Measured by number of occurrences. | 36 months |
| Other urgent interventions for VTE | Measured by number of occurrences. | 36 months |
| Anticoagulation therapy persistence | Estimation of Anticoagulation therapy will be compared to actual total time Anticoagulation therapy was used by patients. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke | Ischemic stroke, hemorrhagic stroke | 36 months |
| Trans Ischemic Attack (TIA) | Measured by number of occurrences. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Sites will be selected at random from a representative list reflecting treatment patterns in each country. Consecutive male and female VTE patients at the randomly selected sited will be included in the registry if they meet the eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Ajay K Kakkar, MD | Thrombosis Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Terence Hart | Muscle Shoals | Alabama | 35662 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18296591 | Background | Heit JA. The epidemiology of venous thromboembolism in the community. Arterioscler Thromb Vasc Biol. 2008 Mar;28(3):370-2. doi: 10.1161/ATVBAHA.108.162545. No abstract available. | |
| 17938798 | Background | Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost. 2007 Oct;98(4):756-64. doi: 10.1160/TH07-03-0212. |
| Label | URL |
|---|---|
| Global Anticoagulant Registry in the FIELD, Venous thromboembolism Event (GARFIELD-VTE) | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 8, 2022 | |
| Reset | Jan 6, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 8, 2022 | Jan 6, 2023 |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D011655 | Pulmonary Embolism |
| D013923 | Thromboembolism |
| D004617 | Embolism |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
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| All cause of mortality |
Causes of death: PE, stroke, cardiac, cancer-related, other... |
| 36 months |
| International Normalized Ratio (INR) Values in Patients treated with Vitamin K Antagonists | Will be assessed by frequency of INR monitoring, and number of INR readings taken before patient achieved optimum range. | 36 months |
| Myocardial Infarction | Measured by number of occurrences of both ST-Elevated Myocardial Infarction and Non-ST Elevated Myocardial Infarction (STEMI/NSTEMI). | 36 months |
| Unstable angina | Measured by number of occurrences. | 36 months |
| Quality of life and patient treatment satisfaction over a three year period | Measured by Questionnaire. | 36 months |
| Background | Eurostat, Eurostat statistics on health and safety 2001. |
| 9521222 | Background | Silverstein MD, Heit JA, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Trends in the incidence of deep vein thrombosis and pulmonary embolism: a 25-year population-based study. Arch Intern Med. 1998 Mar 23;158(6):585-93. doi: 10.1001/archinte.158.6.585. |
| 17296569 | Background | Prandoni P, Noventa F, Ghirarduzzi A, Pengo V, Bernardi E, Pesavento R, Iotti M, Tormene D, Simioni P, Pagnan A. The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients. Haematologica. 2007 Feb;92(2):199-205. doi: 10.3324/haematol.10516. |
| 14718318 | Background | Kahn SR, Ginsberg JS. Relationship between deep venous thrombosis and the postthrombotic syndrome. Arch Intern Med. 2004 Jan 12;164(1):17-26. doi: 10.1001/archinte.164.1.17. |
| 19222476 | Background | Prandoni P, Kahn SR. Post-thrombotic syndrome: prevalence, prognostication and need for progress. Br J Haematol. 2009 May;145(3):286-95. doi: 10.1111/j.1365-2141.2009.07601.x. Epub 2009 Feb 13. |
| 10069756 | Background | Leizorovicz A. Long-term consequences of deep vein thrombosis. Haemostasis. 1998;28 Suppl 3:1-7. doi: 10.1159/000022399. |
| 9666534 | Background | Prandoni P, Lensing AW, Prins MR. Long-term outcomes after deep venous thrombosis of the lower extremities. Vasc Med. 1998;3(1):57-60. doi: 10.1177/1358836X9800300112. |
| 21222564 | Background | Ruppert A, Steinle T, Lees M. Economic burden of venous thromboembolism: a systematic review. J Med Econ. 2011;14(1):65-74. doi: 10.3111/13696998.2010.546465. Epub 2011 Jan 12. |
| 17032933 | Background | MacDougall DA, Feliu AL, Boccuzzi SJ, Lin J. Economic burden of deep-vein thrombosis, pulmonary embolism, and post-thrombotic syndrome. Am J Health Syst Pharm. 2006 Oct 15;63(20 Suppl 6):S5-15. doi: 10.2146/ajhp060388. |
| 15163775 | Background | Pengo V, Lensing AW, Prins MH, Marchiori A, Davidson BL, Tiozzo F, Albanese P, Biasiolo A, Pegoraro C, Iliceto S, Prandoni P; Thromboembolic Pulmonary Hypertension Study Group. Incidence of chronic thromboembolic pulmonary hypertension after pulmonary embolism. N Engl J Med. 2004 May 27;350(22):2257-64. doi: 10.1056/NEJMoa032274. |
| 11157648 | Background | Hyers TM, Agnelli G, Hull RD, Morris TA, Samama M, Tapson V, Weg JG. Antithrombotic therapy for venous thromboembolic disease. Chest. 2001 Jan;119(1 Suppl):176S-193S. doi: 10.1378/chest.119.1_suppl.176s. No abstract available. |
| 15339875 | Background | McRae SJ, Ginsberg JS. Initial treatment of venous thromboembolism. Circulation. 2004 Aug 31;110(9 Suppl 1):I3-9. doi: 10.1161/01.CIR.0000140904.52752.0c. |
| 22315268 | Background | Kearon C, Akl EA, Comerota AJ, Prandoni P, Bounameaux H, Goldhaber SZ, Nelson ME, Wells PS, Gould MK, Dentali F, Crowther M, Kahn SR. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e419S-e496S. doi: 10.1378/chest.11-2301. |
| Background | Adcock, D.M., Recurrence of thromboembolism: determining risk. Clinical Haemostasis Review. 2005. 19:1. |
| 17672809 | Background | Spyropoulos AC, Lin J. Direct medical costs of venous thromboembolism and subsequent hospital readmission rates: an administrative claims analysis from 30 managed care organizations. J Manag Care Pharm. 2007 Jul-Aug;13(6):475-86. doi: 10.18553/jmcp.2007.13.6.475. |
| 25598998 | Background | Summary of Recommendation Statements. Kidney Int Suppl (2011). 2013 Jan;3(1):5-14. doi: 10.1038/kisup.2012.77. No abstract available. |
| 34023735 | Derived | Goto S, Turpie AGG, Farjat AE, Weitz JI, Haas S, Ageno W, Goldhaber SZ, Angchaisuksiri P, Kayani G, MacCallum P, Schellong S, Bounameaux H, Mantovani LG, Prandoni P, Kakkar AK; GARFIELD-VTE investigators. The influence of anemia on clinical outcomes in venous thromboembolism: Results from GARFIELD-VTE. Thromb Res. 2021 Jul;203:155-162. doi: 10.1016/j.thromres.2021.05.007. Epub 2021 May 15. |
| 32583306 | Derived | Weitz JI, Haas S, Ageno W, Goldhaber SZ, Turpie AGG, Goto S, Angchaisuksiri P, Nielsen JD, Kayani G, Farjat AE, Schellong S, Bounameaux H, Mantovani LG, Prandoni P, Kakkar AK; GARFIELD-VTE investigators. Cancer associated thrombosis in everyday practice: perspectives from GARFIELD-VTE. J Thromb Thrombolysis. 2020 Aug;50(2):267-277. doi: 10.1007/s11239-020-02180-x. |
| D012140 |
| Respiratory Tract Diseases |