Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011180
Status:
COMPLETED
Last Update Posted:
2012-12-06
First Post:
2001-02-13
Brief Title:
Risk Factors for Venous Thromboembolism in the Community
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Subtherapeutic Heparin Anticoagulation as a Predictor of Recurrent Venous Thromboembolism A Population-Based Cohort Study
Status:
COMPLETED
Status Verified Date:
2012-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the trends in the incidence of venous thromboembolism to determine the risk factors for venous thromboembolism in patients with medical and surgical illness and to evaluate the efficacy of the anticoagulant therapy in reducing venous thromboembolism
Detailed Description:
BACKGROUND
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL066216 | NIH | None | httpsreporternihgovquickSearchR01HL066216 |