Risk Factors for Venous Thromboembolism in the Community
NCT ID: NCT00011180
Last Updated: 2012-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
385 participants
OBSERVATIONAL
2001-04-30
2009-05-31
Brief Summary
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Detailed Description
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Venous thromboembolism (VTE) occurs frequently among patients hospitalized for major surgery or hospitalized for a medical illness primarily due to prolonged duration of immobilization. However, many patients undergo major surgery without any occurrence of VTE. Standard prophylactic therapy after surgery is heparin, which reduces the risk of VTE. However, heparin is associated with bleeding complications. Thus, it would be desirable to identify patients at high risk for VTE who might benefit the most from heparin therapy. An important focus of the study is to look at genetic factors which might play an important role in VTE incidence.
DESIGN NARRATIVE:
The study is a population based, retrospective case and case-control investigation of the genetic and environmental determinants of venous thromboembolism in the Rochester Minnesota Olmsted County population. The first five years of the study had three specific aims. The first specific aim was to update the 1966-1995 inception cohort to include Olmsted County residents with VTE during the five year period, 1996-2000. The second aim was to extend the analysis of risk factors for VTE by identifying two Olmsted County residents (controls) without VTE matched by age and gender to each definite or probable case within the 1996-2000 cohort, and to obtain plasma and genomic DNA from all cases and controls and perform a case-control study. The third specific aim was to evaluate the efficacy of anticoagulant therapy to prevent VTE recurrence.
The study was extended through March, 2009 to investigate trends in the incidence of venous thromboembolism, new risk factors including lipid-lowering, beta-blocker, and ACE-inhibitor therapies, and introduction of low molecular weight heparin (LMWH) therapy.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Incident Cohort with VTE
Olmsted County, Minnesota residents with with a first-lifetime deep vein thrombosis (DVT) or pulmonary embolism (PE) during the five year period, 1996-2000.
No interventions assigned to this group
Controls without VTE
Two Olmsted County, Minnesota residents without venous thromboembolism (VTE) were matched by age and gender to each definite or probable case of VTE within the 1996-2000 cohort.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Mayo Clinic
OTHER
Principal Investigators
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John Heit, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Heit JA. Mapping out the future in venous thromboembolism and acute coronary syndromes. Semin Thromb Hemost. 2002 Aug;28 Suppl 3:33-9. doi: 10.1055/s-2002-34073.
Heit JA. Venous thromboembolism epidemiology: implications for prevention and management. Semin Thromb Hemost. 2002 Jun;28 Suppl 2:3-13. doi: 10.1055/s-2002-32312.
Heit JA, O'Fallon WM, Petterson TM, Lohse CM, Silverstein MD, Mohr DN, Melton LJ 3rd. Relative impact of risk factors for deep vein thrombosis and pulmonary embolism: a population-based study. Arch Intern Med. 2002 Jun 10;162(11):1245-8. doi: 10.1001/archinte.162.11.1245.
Heit JA. Perioperative management of the chronically anticoagulated patient. J Thromb Thrombolysis. 2001 Sep;12(1):81-7. doi: 10.1023/a:1012746729537.
Heit JA. Risk factors for venous thromboembolism. Clin Chest Med. 2003 Mar;24(1):1-12. doi: 10.1016/s0272-5231(02)00077-1.
Heit JA, Phelps MA, Ward SA, Slusser JP, Petterson TM, De Andrade M. Familial segregation of venous thromboembolism. J Thromb Haemost. 2004 May;2(5):731-6. doi: 10.1111/j.1538-7933.2004.00660.x.
Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost. 2005 Aug;3(8):1611-7. doi: 10.1111/j.1538-7836.2005.01415.x.
Heit JA, Petterson TM, Owen WG, Burke JP, DE Andrade M, Melton LJ 3rd. Thrombomodulin gene polymorphisms or haplotypes as potential risk factors for venous thromboembolism: a population-based case-control study. J Thromb Haemost. 2005 Apr;3(4):710-7. doi: 10.1111/j.1538-7836.2005.01187.x.
Heit JA, Lahr BD, Petterson TM, Bailey KR, Ashrani AA, Melton LJ 3rd. Heparin and warfarin anticoagulation intensity as predictors of recurrence after deep vein thrombosis or pulmonary embolism: a population-based cohort study. Blood. 2011 Nov 3;118(18):4992-9. doi: 10.1182/blood-2011-05-357343. Epub 2011 Sep 2.
Other Identifiers
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864-98
Identifier Type: -
Identifier Source: org_study_id